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

NCT00040807 | Completed Phase 2 FDA Drug

• 2 other identifiers: CDR0000069408ECOG-E3301
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 43

Brief 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.

Conditions

Head and Neck Cancer

Keywords

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

Interventions

docetaxel DRUG

irinotecan hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (43)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305-5216, United States

Location

Medical Center of Aurora - South Campus

Aurora, Colorado, 80012-0000, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301-9019, United States

Location

Penrose Cancer Center

Colorado Springs, Colorado, 80933, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

St. Joseph Hospital

Denver, Colorado, 80218-1191, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers - Denver Rose

Denver, Colorado, 80220, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224, United States

Location

Swedish Medical Center

Englewood, Colorado, 80112, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

St. Mary-Corwin Regional Medical Center

Pueblo, Colorado, 81004, United States

Location

Rocky Mountain Cancer Centers - Thornton

Thornton, Colorado, 80221, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, 60611-4494, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615-7828, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

MBCCOP-Our Lady of Mercy Cancer Center

The Bronx, New York, 10466, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-0001, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226-3596, United States

Location

Related 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 1;115(19):4504-13. doi: 10.1002/cncr.24528.

  PMID: 19634157 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms

Interventions

Docetaxel; Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Athanassios Argiris, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: November 19, 2002
• Primary Completion: April 1, 2005
• Study Completion: May 1, 2009
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (43)