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Home > "C" Clinical Trials Conditions > Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer  Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
For Condition: Salivary Gland Cancer,Oropharyngeal Cancer,lip and oral cavity cancer,Head and Neck Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. 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.
Details: OBJECTIVES: I. Evaluate the response rate and toxicity of weekly cisplatin and gemcitabine in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have received either no prior chemotherapy or no more than one prior chemotherapy regimen for advanced disease. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven squamous cell carcinoma of the head and neck considered incurable with surgery or radiation therapy - Bidimensionally measurable disease or readily evaluable disease by either physical exam or radiography; Biopsy proven recurrence following completion of radiotherapy required if only site of measurable disease is within a previous radiation port --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CoreyLanger, Study Chair, Fox Chase Cancer Center
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
Harrisburg Polyclinic Medical Center
Harrisburg, Pennsylvania, 17101
United States
North Penn Hospital
Lansdale, Pennsylvania, 19446-1200
United States
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
United States
Saint Mary Regional Center
Langhorne, Pennsylvania, 19047
United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
United States
St. Luke's Network - Bethlehem
Bethlehem, Pennsylvania, 18015
United States
Additional Information:
Study ID Numbers: CDR0000066159; FCCC-97021,NCI-G98-1403
Study Start Date: October 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003264
Other Salivary Gland Cancer Studies:
1. Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx
2. Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
3. Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery
4. Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
5. Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia
Related Studies:
Other Salivary Gland Cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Bethlehem Clinical Trials
Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
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