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

Eastern Cooperative Oncology Group

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: docetaxel; Drug: irinotecan hydrochloride

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00040807

CDR0000069408

ECOG-E3301

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the response rate in patients with metastatic or locally recurrent head and neck cancer treated with irinotecan and docetaxel.
• Determine the progression-free and overall survival of patients treated with this regimen.
• Determine the toxic effects of this regimen in these patients.
• Correlate angiogenesis markers and cyclooxygenase-2 expression with response and survival in patients treated with this regimen.
• Correlate UGT1A1 genotype with the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (no prior chemotherapy for locally recurrent or metastatic disease or more than 6 months since prior chemotherapy as primary therapy vs 1 prior chemotherapy regimen for locally recurrent or metastatic disease or less than 6 months since prior chemotherapy as primary therapy).

Patients receive docetaxel IV over 60 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 32-72 patients (16-36 per stratum) will be accrued for this study within 6-14 months.

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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