Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Cisplatin; Irinotecan

Criteria

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma of the head and neck that is considered incurable with surgery or radiotherapy

• Meets one of the following criteria:

• Previously untreated disease

• Newly diagnosed disease with distant metastases

• Recurrent or persistent disease

• Local-regional recurrence/persistence or distant metastases after initial treatment with surgery or radiotherapy

• No locally advanced unresectable disease that was not previously treated with radiotherapy

• Bidimensionally measurable disease

• If the only measurable disease is within the radiotherapy port, there must be biopsy-proven recurrence ≥ 8 weeks after the completion of radiotherapy

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 12 weeks

• Creatinine clearance ≥ 50 mL/min

• SGOT ≤ 3 times upper limit of normal

• Serum bilirubin < 1.5 mg/dL

• Granulocytes ≥ 1,500/mm ^3

• Platelet count > 100,000/mm^3

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No significant detectable infection

• No co-morbid disease unless under adequate control

• No other cancer within the past 3 years except basal cell or squamous cell skin cancer or early-stage prostate cancer

Exclusion Criteria:

-Pregnant or lactating women

Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from any prior major surgery

• No prior chemotherapy for recurrent or metastatic disease

• Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy ≥ 3 months prior to recurrence will be considered chemotherapy-naive

• Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy < 3 months prior to recurrence will be considered chemotherapy failures

• No prior therapy with topotecan or irinotecan hydrochloride

• At least 4 weeks since prior biologic therapy (e.g., interleukin-2, interferon, megestrol acetate)