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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003587 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: vinorelbine ditartrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Phase II Trial of Carboplatin/Gemcitabine Followed By Paclitaxel or Cisplatin/Vinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 160 |
Study Start Date: | October 1998 |
OBJECTIVES: I. Assess the survival and failure free survival of patients with advanced primary non-small cell lung cancer treated with carboplatin and gemcitabine followed by paclitaxel OR cisplatin and vinorelbine followed by docetaxel. II. Evaluate the response (confirmed plus unconfirmed) and toxicities associated with these two regimens in these patients.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8.
Treatment repeats every 21 days for 3 courses. Following the 3 courses of carboplatin and gemcitabine, patients receive paclitaxel IV over 3 hours on day 1 every 21 days for 3 courses. Arm II: Patients receive cisplatin IV over 30-60 minutes on day 1 followed by vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of cisplatin and vinorelbine, patients receive docetaxel IV over 1 hour on day 1 every 21 days for 3 courses. Patients receive no further treatment until evidence of disease progression. Patients are followed every 2 months for the first year, every 6 months for years 2 and 3, and annually thereafter.
PROJECTED ACCRUAL: A total of 160 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 confirmed newly diagnosed stage IIIB or IV advanced primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous cell carcinoma, or unspecified) or recurrent non-small cell lung cancer after previous surgery and/or radiotherapy Stage IIIB: T4 lesion due to malignant pleural effusion, OR multiple lesions in a single lobe containing a T3 or T4 primary, OR lesions in multiple lobes of the ipsilateral lung for which one such lesion is T3 or T4 Any N M0 Stage IV: Any T, Any N, M1 Measurable or evaluable disease Measurable or evaluable disease must be outside of the prior radiotherapy port or prior surgical resection area No brain metastases No bronchoalveolar carcinoma or stage IIIB tumor involving the superior sulcus (pancoast tumors)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 2 times upper limit of normal AND Creatinine clearance at least 50 mL/min Other: No prior malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission Not pregnant or nursing Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for non-small cell lung cancer No concurrent biologic therapy to measurable or evaluable lesions Chemotherapy: No prior systemic chemotherapy for non-small cell lung cancer Endocrine therapy: No concurrent hormonal therapy to measurable or evaluable lesions Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy to measurable lesions Palliative radiation to small field nonmeasurable sites of disease (painful bony metastases) allowed Surgery: At least 3 weeks since surgery (thoracic or other major surgeries) and recovered
Study Chair: | Martin J. Edelman, MD | Veterans Affairs Medical Center - Baltimore |
Study ID Numbers: | CDR0000066656, SWOG-9806 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003587 History of Changes |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer squamous cell lung cancer large cell lung cancer |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Immunologic Factors Vinblastine Docetaxel Respiratory Tract Diseases Cisplatin Lung Neoplasms Gemcitabine Antimitotic Agents Carboplatin Antiviral Agents Immunosuppressive Agents |
Recurrence Carcinoma Vinorelbine Radiation-Sensitizing Agents Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Vinblastine Docetaxel Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses |
Gemcitabine Respiratory Tract Neoplasms Neoplasms by Histologic Type Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Carboplatin Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Vinorelbine Radiation-Sensitizing Agents Paclitaxel |