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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005646 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have extensive-stage small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of Weekly Dose-Dense Paclitaxel in Extensive Stage Small Cell Lung Cancer |
Study Start Date: | April 2000 |
OBJECTIVES: I. Determine the complete and overall response rate to paclitaxel in patients with previously untreated extensive stage small cell lung cancer. II. Determine the overall and progression free survival of these patients in response to this treatment regimen. III. Determine the toxicity of this treatment regimen in this patient population.
OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours weekly for 6 consecutive weeks. Treatment continues every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, then every 3 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study over 8-11 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed extensive stage small cell carcinoma of the bronchus Extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy Measurable disease One lesion that measures at least 20 mm in diameter using conventional techniques or at least 10 mm with spiral CT scan Lesions not considered measurable include: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Cystic lesions Tumor lesions situated in a previously irradiated area Abdominal masses not confirmed and followed by imaging techniques No disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT less than 2 times upper limit of normal Bilirubin less than 1.5 mg/dL Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent hormonal therapy except steroids for renal failure or hormones administered for nondisease related conditions Radiotherapy: At least two weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery: Not specified
United States, Missouri | |
Ellis Fischel Cancer Center - Columbia | |
Columbia, Missouri, United States, 65203 | |
United States, New York | |
State University of New York - Upstate Medical University | |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
Lineberger Comprehensive Cancer Center, UNC | |
Chapel Hill, North Carolina, United States, 27599-7295 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425-0721 |
Study Chair: | Mark A. Socinski, MD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067826, CLB-39901 |
Study First Received: | May 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005646 History of Changes |
Health Authority: | United States: Federal Government |
extensive stage small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Antimitotic Agents Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases Paclitaxel |
Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Tubulin Modulators Neuroepithelioma Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Carcinoma, Neuroendocrine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Respiratory Tract Neoplasms Neoplasms by Histologic Type Mitosis Modulators |
Antimitotic Agents Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |