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Denver, Colorado 80218

  • Head and Neck Cancer


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.

Study summary:

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.


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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

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

Official Title:

Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Athanassios Argiris, MD
Study Chair
Robert H. Lurie Cancer Center

Study Dates

Start Date:October 2002
Primary Completion Date:April 2005
Primary Completion Type:Actual
Verification Date:November 2004
Last Changed Date:July 29, 2009
First Received Date:July 8, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Intervention Type:Drug
Name:irinotecan hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Eastern Cooperative Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Argiris A, Buchanan A, Brockstein B, Kolesar J, Ghebremichael M, Pins M, Hahn K, Axelrod R, Forastiere A. Docetaxel and irinotecan in recurrent or metastatic head and neck cancer: a phase 2 trial of the Eastern Cooperative Oncology Group. Cancer. 2009 Jul 24; [Epub ahead of print]

Data Source:

Date Processed: April 03, 2020

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