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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004139 |
Purpose
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 compare the effectiveness of gemcitabine plus either docetaxel or irinotecan in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: docetaxel Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Phase II Randomized Trial of Gemcitabine/Docetaxel and Gemcitabine/Irinotecan in Stage IIIB/IV Non-Small Cell Lung Cancer |
| Study Start Date: | September 1999 |
OBJECTIVES: I. Compare the complete and overall response rate to gemcitabine and docetaxel versus gemcitabine and irinotecan in chemotherapy naive patients with stage IIIB or IV non-small cell lung cancer. II. Compare the overall and failure free survival, duration of response, and toxicity associated with these combination regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to disease stage (stage IIIB vs stage IV without CNS involvement vs stage IV with CNS involvement vs recurrent/progressive disease post surgery and/or radiotherapy). Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes immediately followed by irinotecan IV over 90 minutes on days 1 and 8. Arm II: Patients receive gemcitabine IV over 30 minutes immediately followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete response or stable disease receive treatment for least 6 courses and for 2 additional courses beyond the maximum response, and then at the investigator's discretion. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter until disease progression or death.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study within 12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB, IV, or recurrent non-small cell lung cancer (NSCLC) including: Squamous cell carcinoma Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic carcinoma (including giant and clear cell carcinomas) Stage IIIB eligible for other CALGB protocols consisting of combined chemotherapy and chest radiotherapy not permitted Malignant pleural effusion allowed CNS metastases allowed following completion of cranial radiotherapy Unidimesionally or bidimensionally measurable disease Solid tumor mass or hilar lesion surrounded by aerated lung Pleural based mass Mediastinal or hilar adenopathy clearly measurable No bone only disease No pleural or pericardial effusions No irradiated lesions unless progression is documented following radiotherapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN if SGOT is greater than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix or breast Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy for NSCLC Endocrine therapy:
Not specified Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy At least 2 weeks since prior whole brain radiotherapy or stereotactic radiotherapy for CNS disease Surgery: At least 2 weeks since prior surgery for CNS disease
Contacts and Locations| United States, District of Columbia | |
| Vincent T. Lombardi Cancer Research Center, Georgetown University | |
| Washington, District of Columbia, United States, 20007 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Missouri | |
| Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| University of Tennessee, Memphis Cancer Center | |
| Memphis, Tennessee, United States, 38163 | |
| Study Chair: | Caio Max S. Rocha Lima, MD | Medical University of South Carolina |
More Information
| Study ID Numbers: | CDR0000067369, CLB-39809 |
| Study First Received: | December 10, 1999 |
| Last Updated: | April 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004139 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent non-small cell lung cancer squamous cell lung cancer large cell lung cancer stage IIIB non-small cell lung cancer |
stage IV non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer |
|
Antimetabolites Thoracic Neoplasms Immunologic Factors Adenocarcinoma, Bronchiolo-Alveolar Irinotecan Immunosuppressive Agents Antiviral Agents Camptothecin Recurrence Carcinoma Docetaxel |
Radiation-Sensitizing Agents Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Gemcitabine Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Irinotecan Docetaxel Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Gemcitabine |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Camptothecin Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
