Status:
COMPLETED
Oxaliplatin and Capecitabine in Treating Patients With Relapsed or Metastatic Head and Neck Cancer
Lead Sponsor:
University of Miami
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gi...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate in patients with chemotherapy naïve relapsed or metastatic head and neck cancer treated with oxaliplatin and capecitabine. Secondary * E...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed head and neck cancer
- Relapsed or metastatic disease
- Measurable disease
- No CNS metastases (unless CNS metastases have been stable for \> 3 months)
- No clinically significant pericardial effusion
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 3 months
- Absolute granulocyte count \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Bilirubin \< 2.0 times upper limit of normal (ULN)
- AST or ALT \< 2.5 times ULN
- Alkaline phosphatase \< 2.5 times ULN (5 times ULN if liver metastases are present or 10 times ULN if bone disease is present)
- Creatinine clearance ≥ 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after completion of study treatment
- No clinically serious, uncontrolled cardiovascular disease
- No New York Heart Association class III-IV heart disease
- No myocardial infarction within the past 6 months
- No congestive heart failure
- No unstable angina
- No arrhythmia
- No concurrent serious, uncontrolled infections
- No other cancer requiring treatment within the past 5 years, except cured nonmelanoma skin cancer or treated in situ cervical cancer
- No loss of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- No history of persistent neurosensory disorder including, but not limited to, peripheral neuropathy
- No history of uncontrolled seizures or CNS disorders
- No history of psychiatric disability or other serious uncontrolled medical condition that would preclude study compliance
- No history of clinically significant interstitial lung disease and/or pulmonary fibrosis
- No prior hypersensitivity or unanticipated severe reaction to fluoropyrimidine therapy, fluorouracil, or platinum-based compounds
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for metastatic or relapsed disease
- More than 4 weeks since prior major surgery and recovered
- More than 4 weeks since prior participation in any investigational drug study
- At least 6 months since prior adjuvant fluoropyrimidine therapy
- No other prior fluoropyrimidines
- At least 6 months since prior adjuvant platinum-based therapy
- No other prior platinum-based therapy
- No concurrent radiotherapy to the head and neck
- No other concurrent chemotherapy
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00448552
Start Date
February 1 2004
End Date
June 1 2008
Last Update
December 15 2016
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136