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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00074204 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and docetaxel, 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. It is not yet known which treatment regimen is more effective for stage IIIB or stage IV non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine and carboplatin followed immediately by docetaxel with that of giving delayed docetaxel 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: docetaxel Drug: gemcitabine hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Study of Delayed vs. Immediate Second-Line Therapy With Docetaxel After Gemcitabine + Carboplatin in Advanced Non-Small Cell Lung Cancer |
Study Start Date: | October 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance status (0 or 1 vs 2).
All patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with stable or responding disease proceed to docetaxel therapy. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life (QOL) is assessed at baseline, at restaging (after completion of gemcitabine and carboplatin), before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment.
NOTE: *For patients randomized to delayed docetaxel, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) 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 or cytologically confirmed non-small cell lung cancer (NSCLC)
Measurable disease or nonmeasurable disease
Nonmeasurable disease, defined as all other lesions, including small lesions (longest diameter less than 20 mm by conventional techniques OR less than 10 mm by spiral CT scan) or any of the following:
No symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No other primary malignancy within the past 5 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or T1 vocal cord cancer in remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Principal Investigator: | Nathan Levitan, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000343695, CASE-CWRU-LILY-1503, LILLY-B9E-US-S245, CASE-1503 |
Study First Received: | December 10, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00074204 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Thoracic Neoplasms Antimetabolites Immunologic Factors Carboplatin Immunosuppressive Agents Antiviral Agents Recurrence Carcinoma Docetaxel |
Radiation-Sensitizing Agents Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Docetaxel Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Gemcitabine |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Carboplatin Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |