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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006487 |
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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: etoposide Drug: tirapazamine Radiation: radiation therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study Of Tirapazamine/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer |
| Study Start Date: | October 2000 |
OBJECTIVES:
OUTLINE: Patients are assigned to one of two induction therapy arms.
Patients with stable or responding disease then receive consolidation therapy consisting of tirapazamine IV over 1 hour and cisplatin IV over 1 hour on day 1 of weeks 11 and 14 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14.
Patients are followed every 2 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No malignant pericardial or pleural effusions, including any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 87 Study Locations| Study Chair: | Quynh-Thu X. Le, MD | Stanford University |
More Information
| Study ID Numbers: | CDR0000068318, SWOG-S0004 |
| Study First Received: | November 6, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006487 History of Changes |
| Health Authority: | United States: Federal Government |
|
limited stage small cell lung cancer |
|
Thoracic Neoplasms Carcinoma, Neuroendocrine Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Etoposide phosphate 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 |