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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066742 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in 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. Tirapazamine may make the tumor cells more sensitive to chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy with tirapazamine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving tirapazamine together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: etoposide Drug: tirapazamine Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of Tirapazamine (NSC-130181)/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer |
| Estimated Enrollment: | 85 |
| Study Start Date: | September 2003 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are followed every 2-3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 30-85 patients will be accrued for this study within 17 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 limited stage small cell lung cancer (SCLC)
Measurable or non-measurable disease by CT scan, MRI, or x-ray
No malignant pericardial or pleural effusion*, defined as 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 134 Study Locations| Study Chair: | Quynh-Thu X. Le, MD | Stanford University |
| Investigator: | Stephen K. Williamson, MD | University of Kansas |
| Investigator: | Primo N. Lara, MD | University of California, Davis |
| Investigator: | Zelanna Goldberg, MD | University of California, Davis |
More Information
| Study ID Numbers: | CDR0000318805, SWOG-S0222 |
| Study First Received: | August 6, 2003 |
| Last Updated: | April 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00066742 History of Changes |
| Health Authority: | United States: Federal Government |
|
limited stage small cell lung cancer |
|
Thoracic Neoplasms Carcinoma, Neuroendocrine Etoposide phosphate Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Tirapazamine Adenocarcinoma Antineoplastic Agents, Phytogenic Etoposide Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Etoposide Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Lung Diseases Tirapazamine Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |