Head and Neck Cancer Clinical Trial
Official title:
Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma
Verified date | June 2023 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | National Cancer Institute (NCI) |
United States,
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
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |