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.

Condition	Treatment or Intervention	Phase
Salivary Gland Cancer lip and oral cavity cancer Head and Neck Cancer Oropharyngeal Cancer	Drug: cisplatin  Drug: gemcitabine	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

New Jersey
      Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County, Mount Holly,  New Jersey,  08060,  United States
      Hunterdon Regional Cancer Center, Flemington,  New Jersey,  08822,  United States
      Riverview Medical Center - Booker Cancer Center, Red Bank,  New Jersey,  07701,  United States
      St. Francis Medical Center, Trenton,  New Jersey,  08629,  United States
Pennsylvania
      Delaware County Memorial Hospital, Drexel Hill,  Pennsylvania,  19026,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      Harrisburg Polyclinic Medical Center, Harrisburg,  Pennsylvania,  17101,  United States
      North Penn Hospital, Lansdale,  Pennsylvania,  19446-1200,  United States
      Paoli Memorial Hospital, Paoli,  Pennsylvania,  19301-1792,  United States
      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States
      Saint Mary Regional Center, Langhorne,  Pennsylvania,  19047,  United States
      St. Luke's Network - Bethlehem, Bethlehem,  Pennsylvania,  18015,  United States

Study chairs or principal investigators

Corey Jay Langer,  Study Chair,  Fox Chase Cancer Center   

Study ID Numbers:  CDR0000066159; FCCC-97021; NCI-G98-1403
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003264
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08