Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
- Registration Number
- NCT00003900
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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 tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and docetaxel in treating patients who have recurrent or metastatic non-small cell lung cancer.
- Detailed Description
OBJECTIVES: I. Evaluate the response rate of previously treated patients with recurrent non-small cell lung cancer after treatment with irinotecan and docetaxel. II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival in this patient population.
OUTLINE: Patients receive irinotecan IV over 90 minutes immediately followed by docetaxel IV over 60 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until death.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description irinotecan + docetaxel docetaxel Patients receive irinotecan IV over 90 minutes immediately followed by docetaxel IV over 60 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until death. irinotecan + docetaxel irinotecan hydrochloride Patients receive irinotecan IV over 90 minutes immediately followed by docetaxel IV over 60 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until death.
- Primary Outcome Measures
Name Time Method response rate Up to 5 years
- Secondary Outcome Measures
Name Time Method overall survival Up to 5 years
Trial Locations
- Locations (19)
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Saskatchewan Cancer Agency
🇨🇦Regina, Saskatchewan, Canada
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CentraCare Clinic
🇺🇸Saint Cloud, Minnesota, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
Quain & Ramstad Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States