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

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00040807

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

78.1

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: docetaxel Drug: irinotecan hydrochloride	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 29, 2002

Actual Primary Completion Date :

Apr 1, 2005

Actual Study Completion Date :

May 1, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
2	Stanford Cancer Center at Stanford University Medical Center	Stanford	California	United States	94305-5216
3	Medical Center of Aurora - South Campus	Aurora	Colorado	United States	80012-0000
4	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
5	Penrose Cancer Center	Colorado Springs	Colorado	United States	80933
6	Porter Adventist Hospital	Denver	Colorado	United States	80210
7	St. Joseph Hospital	Denver	Colorado	United States	80218-1191
8	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
9	Rocky Mountain Cancer Centers - Denver Rose	Denver	Colorado	United States	80220
10	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado	United States	80224
11	Swedish Medical Center	Englewood	Colorado	United States	80112
12	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
13	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80501
14	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
15	Rocky Mountain Cancer Centers - Thornton	Thornton	Colorado	United States	80221
16	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
17	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
18	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
19	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611-4494
20	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611
21	CCOP - Evanston	Evanston	Illinois	United States	60201
22	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615-7828
23	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
24	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
25	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
26	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
27	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
28	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231
29	Tufts - New England Medical Center	Boston	Massachusetts	United States	02111
30	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
31	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
32	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
33	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
34	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
35	Albert Einstein Clinical Cancer Center	Bronx	New York	United States	10461
36	MBCCOP-Our Lady of Mercy Cancer Center	Bronx	New York	United States	10466
37	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43623-3456
38	CCOP - Oklahoma	Tulsa	Oklahoma	United States	74136
39	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104
40	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54307-3453
41	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-0001
42	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin	United States	54449
43	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226-3596