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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel
irinotecan hydrochloride
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Stanford Cancer Center at Stanford University Medical Center
  • Medical Center of Aurora - South Campus
  • Boulder Community Hospital
  • Penrose Cancer Center
  • Porter Adventist Hospital
  • St. Joseph Hospital
  • Presbyterian - St. Luke's Medical Center
  • Rocky Mountain Cancer Centers - Denver Rose
  • CCOP - Colorado Cancer Research Program, Incorporated
  • Swedish Medical Center
  • Sky Ridge Medical Center
  • Hope Cancer Care Center at Longmont United Hospital
  • St. Mary-Corwin Regional Medical Center
  • Rocky Mountain Cancer Centers - Thornton
  • CCOP - Christiana Care Health Services
  • H. Lee Moffitt Cancer Center and Research Institute
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Veterans Affairs Medical Center - Lakeside Chicago
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • CCOP - Evanston
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • CCOP - Wichita
  • MBCCOP - LSU Health Sciences Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Tufts - New England Medical Center
  • CCOP - Kalamazoo
  • West Michigan Cancer Center
  • Mayo Clinic Cancer Center
  • CCOP - Southern Nevada Cancer Research Foundation
  • CCOP - Northern New Jersey
  • Albert Einstein Clinical Cancer Center
  • MBCCOP-Our Lady of Mercy Cancer Center
  • CCOP - Toledo Community Hospital
  • CCOP - Oklahoma
  • CCOP - Sioux Community Cancer Consortium
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • University of Wisconsin Comprehensive Cancer Center
  • CCOP - Marshfield Clinic Research Foundation
  • Medical College of Wisconsin Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2002
Last Updated
June 15, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00040807
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 19, 2002 (Actual)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
May 1, 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanassios Argiris, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Stanford Cancer Center at Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5216
Country
United States
Facility Name
Medical Center of Aurora - South Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012-0000
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-9019
Country
United States
Facility Name
Penrose Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80933
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
St. Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1191
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Denver Rose
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program, Incorporated
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Hope Cancer Care Center at Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
St. Mary-Corwin Regional Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Thornton
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80221
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Veterans Affairs Medical Center - Atlanta (Decatur)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-4494
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Albert Einstein Clinical Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
MBCCOP-Our Lady of Mercy Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
CCOP - Toledo Community Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3453
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19634157
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 Oct 1;115(19):4504-13. doi: 10.1002/cncr.24528.
Results Reference
result

Learn more about this trial

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

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