Clinical trial NCT00040807: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

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