Clinical Research Trials

The following clinical trials are available through the Harvard Head and Neck Oncology Program. This list only summarizes patient eligibility criteria. For specific eligibility inquiries or other questions, please contact the Clinical Research Coordinator listed with each trial.

Investigational Curative Therapy
Chemoprevention
Recurrent Disease
Salivary Gland Cancer
Thyroid Cancer
Phase I Trials
Non-Protocol Treatments

Many of the studies listed below also include a direct link to the National Cancer Institute's PDQ database for more detailed information.

Investigational Curative Therapy

04-006 A Randomized Phase III Trial Comparing Sequential Therapy with TPF/Chemoradiation (ST) To Cisplatin-Based Chemoradiotherapy with Accelerated Concomitant Boost Radiotherapy (CRT) For Locally Advanced Squamous Cell Cancer of the Head and Neck

Objective: 
To compare the three-year survival achieved by Docetaxel/Cisplatin/5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced SCCHN; compare the two-year progression free survival achieved by Docetaxel/Cisplatin/5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced SCCHN; compare survival at five years, progression-free survival at three and five years and the rate of complete response after all therapy; determine and compare site-specific survival within and between each arm; compare functional organ preservation in each arm, the toxicity of each treatment regimen and quality of life; and establish tissue and germ line correlates of response, local regional control, and distant metastases in each arm.

Eligibility: 
Histologically or cytologcially proven squamous cell carcinoma of the head and neck.  Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx.  At least one uni- or bi-dimensionally measurable lesion.  Age ≥18 years.  No previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least five years. Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.

If you have questions or would like further information about this trial, please contact Nancy Livada at (617) 582-8039.

06-128 A Phase I Study of Cetuximab/Docetaxel/Cisplatin/5-Fluorouracil (C-TPF) in Patients with Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Objectives: 

The primary objective for this clinical trial is to determine the maximum tolerated dose of 5-Fluorouracil in Docetaxel/Cisplatin/5-Fluorouracil (TPF) induction chemotherapy when combined with Cetuximab (C) for locally advanced squamous cell cancer of the head and neck (SCCHN). The secondary objectives are to assess the toxicity of the combination and to determine the response rate (Complete Response and Partial Response) of the combined C-TPF in patients with newly diagnosed SCCHN.

Eligibility: 

Histologically or cytologically proven squamous cell carcinoma of the head and neck. Eligible sites: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx or unknown primary site. Stage III or IV disease without evidence of distant metastases. At least one uni- or bi-dimensionally measurable lesion. Age ≥ 18 years. No previous surgery, radiation therapy or chemotherapy for SCCHN (except biopsy or tonsillectomy). No previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.

If you have questions or would like further information about this trial, please contact Nancy Livada at (617) 582-8039.

03-018 Phase II Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With or Without Daily Subcutaneous Amifostine in Patients with Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Objective: 

To determine the rate of local and regional control using carboplatin, paclitaxel, and concomitant boost radiation with or without amifostine at one year after the beginning of treatment, to determine the proportion of patients with chronic xerostomia at 3 and 6 months post-treatment with and without amifostine and those patients with grades 3 or 4 mucositis after radiation with and without amifostine, and to determine the duration of dependence on PEG tubes for subjects with amifostine and without amifostine.

Eligibility: 
Histologically/cytologically proven HNSCC with tumor sites including oral cavity, oropharynx, hypopharynx, larynx, and nasal and paranasal cavities, stage 2, 3, or 4 disease with no evidence of distant metastases, at least one uni-or bidimensionally measurable lesion, no previous radiotherapy or curative surgery for HNSCC, age ≥18 years, induction therapy allowed.

If you have questions or would like further information about this trial, please contact Evan Hempel at (617) 632-5260.

05-401 A Phase I Study of Panitumumab plus Chemoradiotherapy and Induction Chemotherapy in Patients with Locally Advanced Squamous Cancer of the Head and Neck

Primary objective: 
The primary objectives of this study are to identify the maximally tolerated dose (MTD) (or biologically acceptable dose, in the absence of MTD-defining DLT) of paclitaxel given with panitumumab plus carboplatin chemoradiotherapy (Pan-CRT) and to identify the MTD or biologically acceptable dose of TPF, varying the 5-FU dose, given with a fixed dose of panitumumab, prior to concurrent carboplatin, paclitaxel, panitumumab chemoradiotherapy.
Secondary objectives include: 
  1. To evaluate the safety and tolerability of the combination of Pan-CRT
  2. To evaluate the safety and tolerability of Pan-TPF
  3. To estimate the overall response rate (ORR) to Pan-TPF
  4. To estimate the ORR of sequential therapy
  5. To estimate the rate of pathologic complete response (pCR) of primary tumor biopsy after Pan-TPF
  6. To estimate 2-year disease free survival (DFS)
  7. To estimate 2-year overall survival (OS)
  8. To evaluate functional outcome at 2 years with respect to speech, swallowing and overall quality of life (QoL)

Eligibility: 
To be eligible for the study, patients must fulfill all of the following criteria:

If you have questions or would like further information about this trial, please contact Evan Hempel at (617) 632-5260.

06-283 Randomized Phase II Study Of Docetaxel In Combination With ZACTIMA (ZD6474) In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (SCCHN)
Primary Objectives:
Eligibility:
Patients must have: Patients must not have had:

If you have questions or would like further information about this trial, please contact Daniel Sammartino at (617) 632-2503.

Chemoprevention

05-361 Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial

Objective: 
The purpose of this study is to conduct a placebo-controlled, double-blind and randomized 6 month phase IIb cancer control chemoprevention trial of the Bowman-Birk Inhibitor Concentrate (BBIC) in patients with Oral Leukoplakia (OL). This study is being performed to determine whether a product made from soybeans named Bowman-Birk Inhibitor Concentrate (BBIC) affects oral precancerous lesions known as oral leukoplakia (white patch) or erythroplakia (red patch). These types of lesions sometimes, but not always, develop into oral cancer. One of the purposes of this research is to compare the effectiveness of BBIC to an inactive material (called a "placebo") to see if BBIC has any effect on these patches. Another purpose of the study is to see if there are any side effects when taking this medication.

Eligibility: 
Patients must have clinically and histologically proven oral leukoplakia and/or erythroplakia and be ≥18 years of age. Women of childbearing potential must not be pregnant and must be willing to use adequate birth control methods. Patients will not be eligible if there has been the use of systemic steroids, or topical oral steroid preparations within three months of the study.

If you have questions or would like further information about this trial, please contact Daniel Sammartino at (617) 632-2503.

Trials for patients with recurrent disease

05-379: A Phase II, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Proxinum® in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck Who Have Received At Least One Prior Anti-cancer Treatment Regimen for Recurrent Disease

Primary objective:
To determine the safety, tolerability, and recommended dose (RD) of intratumorally injected Proxinium® in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN) who have received at least one prior anti-cancer treatment regimen for recurrent disease
Secondary objectives:
Eligibility: 

If you have questions or would like further information about this trial, please contact Nancy Livada at (617) 582-8039.

04-358: A Phase II Study of Single-Agent Depsipeptide in Patients with Unresectable or Metastatic Squamous Cell Carcinoma of the Head and Neck

Primary objective: 
The primary objective of this study is to evaluate the rate of disease control (i.e., achievement of complete response, partial response, or stable disease) of the single agent depsipeptide in patients with unresectable recurrent or metastatic squamous cell carcinoma of the head and neck.
Secondary objective: 
The secondary objective of this study is to evaluate the duration of response, time to progression, and overall survival for patients with incurable head and neck cancer treated with depsipeptide.
Eligibility: 
To be eligible for the study, patients must fulfill all of the following criteria:

If you have questions or would like further information about this trial, please contact Evan Hempel at (617) 632-5260.

06-111 Randomized Phase II Study of Bevacizumab/Tarceva® and Tarceva®/Sulindac in Squamous Cell Carcinoma of the Head and Neck

Primary Objective: 

The primary objective of this randomized Phase II study is to evaluate the efficacy of erlotinib (also called Tarceva®) plus bevacizumab (also called Avastin®) (Arm A) or erlotinib (Tarceva®) plus sulindac (Arm B) in subjects with incurable recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), as measured by progression-free survival (PFS).

Secondary Objective: 

Secondary objectives include: evaluation of the overall response rate (ORR) of erlotinib (Tarceva®) plus bevacizumab (Avastin®) or sulindac in subjects with incurable SCCHN; evaluation of the duration of overall survival and objective response with erlotinib (Tarceva®) plus bevacizumab (Avastin®) or sulindac in this patient population (rates of PFS at 4 months and 1 year will also be determined); evaluation of the safety and side effects of erlotinib (Tarceva®) plus bevacizumab (Avastin®) or sulindac in subjects with incurable SCCHN; and to bank pre- and post-treatment tissue specimens in a subset of subjects for exploration molecular markers associated with response.

Eligibility: 

Subjects must be 18 years of age or older with histologically/ cytologically documented squamous cell carcinoma of the head and neck. Subjects must have evaluable locoregional and/or metastatic disease that is not appropriate for treatment by primary surgical resection or radiotherapy. Subjects must have failed to respond to or relapsed from at least once prior chemotherapy or chemoradiotherapy. Subjects will be excluded from this study if they have had: more than one prior systemic therapy for recurrent and/or metastatic disease, any other malignancy within 5 years (except non-melanomatous skin cancer, or carcinoma in situ of the cervix, bladder or head and neck), concurrent anticancer therapy (other than that of this study), treatment with any anticancer drug within 28 days of beginning this study, radiotherapy within 28 days of beginning this study, any prior therapy which targets the ErbB and/or VEGF pathways (including oral kinase inhibitors and antibody therapy), concurrent therapy with any NSAID (except aspirin at a dose of no more than 81 mg per day), known hypersensitivity characterized by acute bronchospasm, urticaria and/or rhinitis to NSAIDs (including aspirin). Subjects will also be excluded form this study if they have other serious illnesses or medical conditions, a tumor that encases the carotid artery (or other major vessel that in the opinion of investigators is at risk for tumor-related hemorrhage), or have the presence of central nervous system or brain metastases.

If you have questions or would like further information about this trial, please contact Evan Hempel at (617)632-5260.

06-189 A Phase II Study of ARQ 501 in Patients with Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (ARQ 501-208)
Objective: 

The primary objective of this Phase II study of ARQ 501 is to assess the overall response rate (ORR) of patients with locally advanced or metastatic squamous cell carcinoma of the head and neck (SCCHN) to ARQ 501, as measured by scans done every eight weeks and evaluated by Response Evaluation Criteria in Solid Tumors (RECIST). Secondary objects will include determining the progression-free survival (PFS) at six months for those patients treated with ARQ 501, and further characterizing the safety of ARQ 501.

Eligibility: 

The patient population enrolled in this study will be adult patients with locally advanced, recurrent, or metastatic SCCHN with documented measurable disease according RECIST, who have not received greater than or equal to 3 prior anti-cancer therapies and have a Karnofsky performance status greater than or equal to 70%. Patients with primary tumors of nasopharyngeal origin, those who are eligible for curative surgery or radiotherapy, and those who have active uncontrolled systemic infection considered opportunistic, life threatening of clinically significant at the time of treatment, will not be eligible for this study. Patients who are pregnant or lactating, who have had previous exposure to ARQ 501, who have symptomatic or untreated central nervous system (CNS) involvement, or who have had surgery within two weeks of the first infusion, will be excluded. Subjects must not have received anticancer chemotherapy, immunotherapy, radiotherapy or investigational agents within three weeks of their first infusion.

If you have questions or would like further information about this trial, please contact Evan Hempel at (617)632-5260.

Salivary Gland Cancer

04-149 Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients with Locally Advanced, Incurable, Salivary Gland Cancers

Objective: 
The primary objective of this study is to evaluate the tumor response rate of chemo naive patients with incurable salivary gland cancer treated with XELOX.  Secondary objectives are to evaluate the time to progression, toxicity profile (safety) and to determine the expression of signal transduction/cell cycle regulatory proteins.

Eligibility: 
Histologically confirmed diagnosis of any of the following malignancies originating from salivary tissue: adenoid cystic carcinoma, mucoepidermoid carcinoma, acinic cell carcinoma, malignant mixed tumor, polymorphous low grade adenocarcinoma, undifferentiated carcinoma, squamous cell carcinoma, adenocarcinoma.  Patients must be incurable on the basis of unresectable local or distant disease as determined by the patient's surgeon and not be potentially curable by radiation therapy as determined by a radiation oncologist. Patients may have received radiation to any site with the following caveat:  the sites used for evaluation for response are either not previously irradiated or they have shown progression of disease post radiation and there has been a time interval of one month since these sites were radiated. Age ≥18 years.  Measurable disease.

If you have questions or would like further information about this trial, please contact Daniel Sammartino at (617) 632-2503.

Thyroid Cancer

06-188 A Phase II, Open-Label Study to Assess the Efficacy and Tolerability of ZD6474 (ZACTIMA) 100 mg Monotherapy In Subjects with Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer.
Objective:

The primary objective of this study is to determine the objective response rate in subjects treated with ZD6474 monotherapy. Secondary objectives are to determine the safety and tolerability of ZD6474 treatment in this patient population, to determine the progression free survival of hereditary MTC in subjects following ZD6474 100 mg therapy, as well as the disease control rate, duration of objective response, and duration of disease control with ZD6474. Secondary objectives also include assessment of performance status as well as bowel frequency changes during therapy, in addition to an assessment of the effect of ZD6474 on calcitonin and CEA levels, and to characterize the population pharmacokinetic of ZD6474 in subjects with hereditary MTC.

Eligibility

Potiential subjects must be over 18 years of age, WHO Performance status of 0-2, at least one measureable lesion greater than 1 cm on spiral CT, and women of childbearing potential must have a negative pregnancy test. Only subjects with the hereditary form of medullary thyroid cancer will be eligible for entry into this trial. Subjects must not have brain metastases or spinal cord compression, unless irradiated at least four weeks before the first dose and stable without steroid treatment for greater than one week. Subjects must have had their last surgical procedure, dose of chemotherapy or radiation, at least four weeks before starting study. Subjects must not have significant cardiac issues that put them at risk of ventricular arrhythmia, or asymptomatic sustained ventricular tachycradia, or congenital long QT syndrome, or first degree relative with unexplained death under 40 years of age. Subjects cannot have a left bundle branch block, uncontrolled hypertension, previous malignancies at other sites within five years of study start, with the exception of in situ carcinoma of the cervix and basal or squamous cell carcinoma of the skin.

Compensation:

There may be funds available to aid any patient who wishes to participate, but will require a large travel expenditure. Details regarding travel reimbursement may be discussed further with the study staff.

If you have questions or would like further information about this trial, please contact Daniel Sammartino at (617) 632-2503.

06-252 A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMA) versus Placebo in Subjects with Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer
Objective: 

This will be a Phase II, randomized study to establish the effect of once-daily oral doses of ZD6474 300mg vs placebo in subjects with locally advanced or metastatic hereditary or sporadic medullary thyroid cancer in whom no standard therapeutic option is available.

It will be conducted in a minimum of 232 subjects in approximately 58 countries. The subjects may continue with ZD6474 as long as they are receiving clinical benefit or until they are given another anti-cancer therapy.

Eligibility: 

To participate in study you must:

Be 18 years or older ; Have confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC ; Have a measurable tumor; Be able to swallow medication

You are not able to participate if you have:

Had major surgery within 4 weeks before randomization; Received the last dose of prior chemotherapy less than 4 weeks prior to randomization; Had radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy); Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days; Significant cardiac events; Had previous ZD6474 treatment

If you have questions or would like further information about this trial, please contact Daniel Sammartino at (617) 632-2503.

06-321 A Pivotal Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients with 131I-refractory metastatic or Unresectable locally-advanced papillary, follicular, or Hurthle-cell thyroid cancer who are also refractory to, or intolerant of, or have clinical contraindication to, doxorubicin treatment
Primary Objective: 

The primary objective of this study is to determine the objective response rate (ORR) of patients with 131I-refractory metastatic or unresectable locally-advanced papillary, follicular, or Hurthle-cell thyroid cancer who are also refractory to, or intolerant of, or have clinical contraindication to, doxorubicin treatment.

Inclusion Criteria:
  1. Histologically documented, 131I-refractory metastatic or unresectable locally-advanced thyroid cancer of papillary, follicular or Hurthle cell histology.
    • Failure of doxorubicin (either as a single agent or in combination with other agents) to control the disease, documented with radiographic evidence of disease progression as defined by RECIST criteria and documented with 2 sets of CT/MRI scans or 2 sets of chest x-rays during doxorubicin therapy or within 6 months after the last dose of doxorubicin (scans or chest x-rays must be received and verified by imaging core laboratory before patient can receive treatment);
    • Intolerance of doxorubicin therapy, defined as occurrence of life-threatening or grade 4 toxicity attributable to previous therapy with doxorubicin (a maximum of 10 patients will be eligible under this criteria);
    • Doxorubicin therapy is clinically contraindicated, defined as patients who have received a cumulative doxorubicin dose of >450 mg/m2 during previous therapy.
  2. If a patient has only locally-advanced cancer without distant metastasis, in addition to satisfying the above inclusion criteria, the disease must also be unresectable (eg, tumor involving vital structure, history of previous surgery in the same area, or concurrent severe medical condition that prevents surgery) AND must be refractory to external beam radiotherapy.
  3. At least 1 measurable target lesion, as defined by RECIST. If the only measurable target lesion is located in an externally irradiated field, this lesion may be used as measurable disease only if the lesion diameter has grown by≥20 % since completion of the prior external irradiation or if the lesion is a new lesion, assuming all other criteria are met (CT/MRI scans must be received and verified by imaging core laboratory before patient can receive treatment). Baseline scans must be received by the imaging core laboratory before the patient can receive treatment with AG-013736.
  4. Adequate hepatic, and renal function documented within 14 days prior to treatment as documented by:
    • AST and ALT ≤2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT ≤5.0 x ULN
    • total bilirubin ≤1.5 x ULN
    • serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥60 mL/min
    • urinary protein <2+ by urine dipstick. If dipstick is ≥2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours
  5. Age ≥18 years.
  6. ECOG performance status of 0 or 1 (see Appendix D)
  7. No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be ≤140, and the baseline diastolic blood pressure readings must be ≤90. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
  8. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to treatment.
Exclusion Criteria:
  1. Central lung lesions involving major blood vessels (arteries or veins). (Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
  2. Thyroid lymphoma or anaplastic or medullary histology
  3. Bleeding from lung (as evidenced by hemoptysis) > 1/2 tsp of bright red blood per day within past 1 week
  4. Gastrointestinal abnormalities including:
    • inability to take oral medication
    • requirement for intravenous alimentation
    • prior surgical procedures affecting absorption including gastric resection
    • treatment for active peptic ulcer disease in the past 6 months
    • active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy.
    • malabsorption syndromes.
  5. Previous treatment with anti-angiogenesis agents including thalidomide, Sutent (SU-011248), AMG 706, sorafenib, and bevacizumab.
  6. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, ergot derivatives, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, and delavirdine).
  7. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, and St. John's wort).
  8. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
  9. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
  10. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism.
  11. History of a malignancy (other than thyroid cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
  12. Major surgical procedure within 4 weeks of treatment.
  13. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
  14. Patients (male and female) having procreative potential who are not using adequate contraception or practicing abstinence.
  15. Women who are pregnant or breast-feeding.

If you have questions or would like further information about this trial, please contact Daniel Sammartino at (617) 632-2503.

Phase I Trials

06-416 An Open-Label, Randomized, Phase 1b Study Evaluating the Effect of Different Doses of AMG 706 on the Gallbladder in Subjects with Advanced Solid Tumors
Primary Objective: 
The primary objective of this study is to evaluate the effect of AMG 706 monotherapy administered according to three different dosing schemes on the change in size (volume) and function (eject fraction) of the gallbladder.
Secondary Objective(s): 
Eligibility: 
Key Inclusion Criteria:
Key Exclusion Criteria:

For further information on this study, please contact the research coordinator for this trial, Jayme Flynn at (617) 632-5260.

Non-protocol treatments

Salivary gland cancer/adenoid cystic carcinoma: 
Second line chemotherapy with Cytoxan, Adriamycin and Oxaliplatin for patients who have not had prior exposure to these three drugs and who have progressed on other chemotherapy for metastatic or recurrent disease.  Cycles are every 3-4 weeks.

Recurrent or metastatic nasopharynx cancer: 
First line salvage for possible cure.  ABIM (Adriamycin, Bleomycin, Ifosfamide and Mesna).  Patients with metastatic disease, or locally recurrent disease for which further radiation is not recommended, no prior systemic chemotherapy for recurrence, no radiation to sites outside the head and neck.  This therapy requires hospitalization for 4 days, a venous access device and careful monitoring.  Cycles are every three to four weeks. Radiotherapy is planned for limited stage recurrences.