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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040807
• Other study ID #: CDR0000069408
• Secondary ID: ECOG-E3301
• Status: Completed
• Phase: Phase 2
• Start date: November 19, 2002
• Est. completion date: May 1, 2009

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 1, 2009
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• docetaxel

• irinotecan hydrochloride

Locations

Country	Name	City	State
United States	Medical Center of Aurora - South Campus	Aurora	Colorado
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Tufts - New England Medical Center	Boston	Massachusetts
United States	Boulder Community Hospital	Boulder	Colorado
United States	Albert Einstein Clinical Cancer Center	Bronx	New York
United States	MBCCOP-Our Lady of Mercy Cancer Center	Bronx	New York
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois
United States	Penrose Cancer Center	Colorado Springs	Colorado
United States	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia
United States	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado
United States	Porter Adventist Hospital	Denver	Colorado
United States	Presbyterian - St. Luke's Medical Center	Denver	Colorado
United States	Rocky Mountain Cancer Centers - Denver Rose	Denver	Colorado
United States	St. Joseph Hospital	Denver	Colorado
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	Swedish Medical Center	Englewood	Colorado
United States	CCOP - Evanston	Evanston	Illinois
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Sky Ridge Medical Center	Lone Tree	Colorado
United States	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	Stanford Cancer Center at Stanford University Medical Center	Stanford	California
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Rocky Mountain Cancer Centers - Thornton	Thornton	Colorado
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	CCOP - Oklahoma	Tulsa	Oklahoma
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Oct — View Citation