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Principal Name   Harvey Zimbler, MD
Contact Name   Gloria Gero
Phone   (413) 496-8205
Alternate Phone   (413) 443-6000
Fax   (413) 443-2203
Title   E1305 - "A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer"
Description  
SCHEMA

Primary Objective

To compare the overall survival of patients with recurrent or metastatic head and neck cancer treated with standard platinum-based chemotherapy with or without bevacizxumab


SCHEMA

ARM A
Platinum-doublet
Every 21 days until disease proagression > Option to discontinue chemotherapy after cycles if manimum response

ARM B
Bevacizumab 15 mg/kg IV, day 1
Platinum -doublet
Every 21 days until disease progression > Option to discontinue chemotherapy after 6 cycles if manimum response.
Bevacizumab will be continued until progression
Treatment   Oncology
Inclusion/Notes   ELIGIBILITY/INELIGIBILITY

-Patients must have histologically or cytologically confirmed Squamous Cell Cancer of the Head and Neck (SCCHN),
from any primary site, including unknown primary cancer of the head and neck. Patient must not have
nasopharyngeal carcinoma of histologic types WHO 2 or 3 or squamous cell carcinoma that originated in the skin.
- Patient must SCCHN that is either (a) recurrent, judged incurable by surgery or radiation or (b) metastatic
- No prior chemotherapy or biologic/molecular targeted therapy for recurrent or metastatic SCCHN
- No prior bevacizumab is allowed
- A maximum of one prior radiotherapy regimen, curative or palliative, to the head and ncek is allowed. If radiation
is combined with chemotherapy and/or cetuximab, a minimum of 4 months must elapse betweent the end of
radiotherapy ad registration. If radiatin is given alone, a minimum of 8 weeks must elapse between the end of
radiotherapy and registration.
- Patients must not be receiving any ohter investigational agent while on study.
-ECOG PS of 0-1
- Patients must have recovered to grade 1 or better from any acute effects of prior surgery, chemotherapy, or
radiaiton therapy, and should be >4 weeks post surgery.
- Patients must have measurable disease based on RECIST. Baseline measurements and evaluations of all sites of
disease must be obtained <4 weeks prior to randomzation. Disease in previously irradiated sites is considered
measurable if there has been unequivocal disease progressoin or biopsy-proven residual carcinoma folloiwng
radiation therapy.
Persistent disease after radiotherapy must be biopsy proven at least 8 weeks after completion of radiation therapy.
- Baselin eparamaters: < 2 weeks prior to randomizatoin
ANC >1500/mm3
Hgb >8.0 g/dl
Platelet count> 100,000/mm3
Creatinine clearance of > 60m./min Use Cockroft-Gault formula
- Total bilirubin within normal limits:
- Alkaline phsophatase, SGOT (AST) and SGPT (ALT) values must be obtained <2 weeks prior to randomzaiton.
- Urine dipstickk must be < 0-1+ within 2 weeks (14 days) of randomizatoin. If urine dipstick result is >1+, a
calculation of UPC ratio is required. Patients must have a UPC ratio <1.0 to participate in the study.
- No known brain metastatses
- Patients who meet the following criteria will be excluded due to the possibility of increased risk for tumor bleeding
with bevacizumab therapy
- No history of coagulopathy or hemorrhagic disorders
- Patient should not have history of thrombiss currently requiring therapeutic anticoagulation and INR should be <1.5
at registration
- Patients must not be receiving chronic daily treatment with aspirin (>325 mg/day) or non-steroidal anti-inflammatory
agents )NSAID's) known to inhibit platelet function.
- No hypercalcemia related to head and neck cancer.
- Patients with prior history of squamous cell or basal carcinoma of skin or in situ cervical cancer must have been
curatively treated.
- No current peripheral neuropathy> grade 2 at time of randomizaiton
- Patients must not have any co-existing condition that would preclude full complilance with the study
- All patients must have blood pressure <150/90 < 2 weeks prior to randomization. Patients with history of
hypertension must be well-controlled upon study entry (<150/90) on a stable regimen of antihypertensive therapy.
- No major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the study
enrollment, or anticipation of need for major surgical procedure during the course of the study.
- No unstable angina or myocardial infaction within the preivous 6 months; no symptomatic congestive heart failure,
New York Heart Assocation Grade II or greater;
- age > 18 years
- women must not be pregnant or breast feeding
- All females of childbearing potential must have a blood test or urine study wihtin 2 weeks prior to randomization to
rule out pregnancy.
- HIV-positive patients receiving comination anti-retroviral therapy are excluded from the study because of possible
drug interactions with study drugs.
Status   accruing
Current Trial Type   treatment


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