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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 cancer cells.

PURPOSE: Phase II trial to study the effectiveness of irinotecan and docetaxel in treating patients who have metastatic or locally recurrent head and neck cancer.

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

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Docetaxel; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed carcinoma of the head and neck

• Squamous cell carcinoma

• No WHO grade II or III nasopharyngeal carcinoma (well-differentiated nasopharyngeal carcinoma allowed)

• Metastatic or locally recurrent disease considered to be incurable by locoregional therapy

• Unidimensionally measurable disease outside previously irradiated field unless documented progressive disease or histologically confirmed residual carcinoma at least 8 weeks after completion of radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal

• AST and ALT less than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR

• Alkaline phosphatase less than 4 times ULN and AST and ALT normal

Renal:

• Creatinine less than 2.0 mg/dL

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• No active infection

• No pre-existing grade 2 or greater peripheral neuropathy

• No other concurrent medical condition that would preclude study participation

• No hypersensitivity to drugs formulated with Polysorbate 80

• No other malignancy within the past 3 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 2 weeks since prior biologic therapy

• Any number of prior biologic therapies (e.g., chimeric antibodies or kinase inhibitors) allowed

• No concurrent filgrastim (G-CSF)

Chemotherapy:

• At least 4 weeks since prior chemotherapy

• No prior docetaxel or irinotecan

• No more than 1 prior chemotherapy regimen for recurrent or metastatic disease

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy for recurrent or metastatic disease and recovered

Surgery:

• Recovered from prior surgery

Other:

• No concurrent antiepileptics

• No concurrent cyclosporine