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Sponsored by: |
Japan Multinational Trial Organization |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00104793 |
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 irinotecan together with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: irinotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer |
Estimated Enrollment: | 55 |
Study Start Date: | June 2003 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses.
PROJECTED ACCRUAL: A total of 55 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
No massive pleural or pericardial effusion by chest CT scan
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No prior radiotherapy to the chest
Surgery
Japan | |
National Hospital Organization - Medical Center of Kure | |
Hiroshima, Japan, 737-0023 | |
Gunma Cancer Center | |
Gunma, Japan, 373-8550 | |
Osaka Kosei Nenkin Hospital | |
Osaka, Japan, 553-0003 | |
Tokyo Medical and Dental University | |
Tokyo, Japan, 113-8519 | |
Japan, Hokkaido | |
National Hospital Organization - Dohoku National Hospital | |
Asahikawa, Hokkaido, Japan, 070-0901 | |
Japan, Kanagawa | |
Fujisawa City Hospital | |
Fujisawa, Kanagawa, Japan, 251-8550 | |
Japan, Okayama | |
Kurashiki Central Hospital | |
Kurashiki-shi, Okayama, Japan, 710-8602 | |
Japan, Osaka | |
National Hospital Organization - Osaka National Hospital | |
Sakai, Osaka, Japan, 591-8555 | |
Osaka General Medical Center | |
Osaka-shi, Osaka, Japan, 558-0056 | |
Takatsuki Red Cross Hospital | |
Takatsuki, Osaka, Japan, 569-1096 | |
Yao Tokusyu-kai General Hospital | |
Yao, Osaka, Japan, 561-0072 |
Study Chair: | Tadashi Mio, MD | Kyoto University |
Study ID Numbers: | CDR0000415703, JMTO-LC02-02 |
Study First Received: | March 3, 2005 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00104793 |
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 |