Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
NCT ID: NCT00003264
Last Updated: 2013-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
1997-10-31
2002-06-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of cisplatin plus gemcitabine in treating patients with advanced squamous cell head and neck cancer that cannot be treated by surgery or radiation therapy.
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Detailed Description
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OUTLINE: Patients are stratified according to prior chemotherapy status: chemotherapy naive (no prior chemotherapy, or prior neoadjuvant or adjuvant chemotherapy at least 6 months prior to recurrence, or prior biologic agents only) vs chemotherapy exposed (one prior chemotherapy regimen directed at recurrent or newly diagnosed metastatic disease and/or prior neoadjuvant or adjuvant chemotherapy less than 6 months prior to recurrence). Patients receive gemcitabine as a 30 minute infusion weekly for 3 weeks followed by one week of rest. Cisplatin is administered as a 30-60 minute infusion immediately preceding gemcitabine. Treatment repeats every 28 days for 2-6 courses, depending on response. Patients with previously untreated metastatic disease may have treatment interrupted to receive radiation therapy to locoregional disease sites. Patients may continue treatment beyond 6 courses at the discretion of the physician. Patients are followed every 3 months.
PROJECTED ACCRUAL: This study will accrue approximately 36 patients.
Conditions
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Study Design
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TREATMENT
Interventions
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cisplatin
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Neurologic: Peripheral sensory neuropathy no greater than grade 1 Other: No significant active infection (patients with WBC of 12,000/mm3 or greater, or fever of 100.6 degrees F or higher, must be evaluated to rule out occult infection) Not pregnant or nursing Effective contraception required of fertile patients No active second malignancy
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy (interleukin-2, interferon, monoclonal antibodies, and/or retinoids) permitted Recovered from prior biologic therapy Chemotherapy: No more than one prior chemotherapy regimen for advanced or relapsed disease No chemotherapy within 4 weeks prior to study Prior neoadjuvant or radiosensitizing chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy permitted Recovered from prior radiotherapy Surgery: Recovered from major surgery
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fox Chase Cancer Center
OTHER
Principal Investigators
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Corey J. Langer, MD
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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Hunterdon Regional Cancer Center
Flemington, New Jersey, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, United States
St. Francis Medical Center
Trenton, New Jersey, United States
St. Luke's Network - Bethlehem
Bethlehem, Pennsylvania, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Harrisburg Polyclinic Medical Center
Harrisburg, Pennsylvania, United States
Saint Mary Regional Center
Langhorne, Pennsylvania, United States
North Penn Hospital
Lansdale, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Countries
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Other Identifiers
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FCCC-97021
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-G98-1403
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000066159
Identifier Type: -
Identifier Source: org_study_id
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