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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00040807 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: docetaxel Drug: irinotecan hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma |
| Study Start Date: | October 2002 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed carcinoma of the head and neck
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 43 Study Locations| Study Chair: | Athanassios Argiris, MD | Robert H. Lurie Cancer Center |
More Information
| Study ID Numbers: | CDR0000069408, ECOG-E3301 |
| Study First Received: | July 8, 2002 |
| Last Updated: | July 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00040807 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent metastatic squamous neck cancer with occult primary metastatic squamous neck cancer with occult primary squamous cell carcinoma stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the hypopharynx |
recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer salivary gland squamous cell carcinoma stage IV salivary gland cancer |
|
Docetaxel Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Head and Neck Neoplasms Irinotecan Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions Camptothecin |