Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI ECOG-E3301 E3301, NCT00040807

Objectives

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

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Athanassios Argiris, MD, Protocol chair(Contact information may not be current)		Ph: 312-695-4441

Registry Information
Official Title		Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma
Trial Start Date		2002-10-29
Registered in ClinicalTrials.gov		NCT00040807
Date Submitted to PDQ		2002-05-02
Information Last Verified		2004-11-23
NCI Grant/Contract Number		U10-CA21115

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