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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00469898 |
RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works as first-line therapy in treating patients with extensive-stage small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: irinotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Carboplatin and Irinotecan (CPT-11) as First-Line Therapy for Patients With Extensive Stage Small Cell Lung Cancer |
Estimated Enrollment: | 54 |
Study Start Date: | December 2003 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label study.
Patients receive irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 and carboplatin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer (SCLC)
Must have ≥ 1 unidimensionally measurable lesion (longest diameter to be recorded) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
Lesions that are considered nonmeasurable include the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 7 days since prior phenytoin, phenobarbital, carbamazepine, or other enzyme-inducing anticonvulsant drugs
United States, Tennessee | |
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee | |
Knoxville, Tennessee, United States, 37901 | |
MBCCOP - Meharry Medical College - Nashville | |
Nashville, Tennessee, United States, 37208 | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232-6838 | |
West Tennessee Cancer Center at Jackson-Madison County General Hospital | |
Jackson, Tennessee, United States, 38301 | |
Canada | |
British Columbia Cancer Agency - Vancouver Cancer Centre | |
Vancouver, Canada, V52 4 |
Principal Investigator: | Alan B. Sandler, MD | Vanderbilt-Ingram Cancer Center |
Responsible Party: | Vanderbilt-Ingram Cancer Center ( Alan B. Sandler ) |
Study ID Numbers: | CDR0000543773, VU-VICC-THO-0321 |
Study First Received: | May 3, 2007 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00469898 |
Health Authority: | United States: Federal Government |
extensive stage small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Irinotecan Carboplatin Camptothecin Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell |
Neuroectodermal Tumors Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |