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Sponsored by: |
University of Saskatchewan |
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Information provided by: | University of Saskatchewan |
ClinicalTrials.gov Identifier: | NCT00259675 |
To see the efficacy of using chemotherapies alternatively (carboplatin and gemcitabine alternating with carboplatin and taxol) for pts with stage IIIB (nonresectable and stage IV NSCLC.
Condition | Intervention | Phase |
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Non Small Cell Lung Cancer |
Drug: carboplatin/gemcitabine, carboplatin/taxol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | Treatment of Stages IIIB and IV, Non Small Cell Lung Cancer With Alternating Cycles of Carboplatin/Taxol and Carboplatin/Gemcitabine. |
Estimated Enrollment: | 100 |
Study Start Date: | May 2004 |
Study Completion Date: | May 2007 |
Ages Eligible for Study: | 19 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of measurable or evaluable disease on physical examination, CT scan, chest x-ray, ultrasound or MRI scan.
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Exclusion Criteria:
1 ) Previous chemotherapy for NSCLC.
2) Known CNS metastases at time of registration.
3) Laboratory values obtained <28 days prior to entry
ANC <1.5 x 109 /L PLT <100 x 109 /L HgB<100 g/L Total bili >1.5 x UNL (upper normal limit) Alk PO4 >3 x UNL AST >3x UNL Cr >1.5 x UNL.
4) Uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other disease which in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient.
5) Known HIV positive.
6) Palliative radiotherapy to only area of measurable disease.
7) Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated non invasive carcinomas, or other cancer from which the patient has been disease free for at least five years.
8) Pregnant or nursing women. Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, IUD, abstinence, surgical sterilization etc).
Study ID Numbers: | BIO-REB 04-99 |
Study First Received: | November 28, 2005 |
Last Updated: | November 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00259675 |
Health Authority: | Canada: Ethics Review Committee |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases |
Carboplatin Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors |
Antimitotic Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |