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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: | NCT00033696 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: filgrastim Drug: carboplatin Drug: etoposide Drug: paclitaxel Drug: topotecan hydrochloride Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Paclitaxel/Topotecan/Etoposide (EtopoTax) Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study |
| Study Start Date: | September 2001 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients with rapid disease progression discontinue study therapy.
Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10 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 small cell lung cancer
Measurable disease
Lesions not considered measurable include the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent hormonal therapy except:
Radiotherapy:
Surgery:
Contacts and Locations
Show 51 Study Locations| Study Chair: | Antonius A. Miller, MD | Wake Forest University |
More Information
| Study ID Numbers: | CDR0000069313, CLB-30002 |
| Study First Received: | April 9, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00033696 History of Changes |
| Health Authority: | United States: Federal Government |
|
limited stage small cell lung cancer |
|
Thoracic Neoplasms Carcinoma, Neuroendocrine Antimitotic Agents Carboplatin Etoposide phosphate Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases Paclitaxel |
Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Tubulin Modulators Neuroepithelioma Topotecan Adenocarcinoma Antineoplastic Agents, Phytogenic Etoposide Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Etoposide Respiratory Tract Neoplasms Neoplasms by Histologic Type Mitosis Modulators Enzyme Inhibitors |
Antimitotic Agents Carboplatin Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Adenocarcinoma Topotecan Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |