Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00003264
• Lead Sponsor: Fox Chase Cancer Center

Brief Summary

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.

Detailed Description

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.

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.

Study Timeline

• Study Start: 1997-10
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-02
• Study Completion: 2002-06
• Study First Submitted QC: 2004-02-27
• Study First Posted: 2004-03-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-16
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (12)

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

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