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Study 10 of 884 for search of: | United States, Delaware |
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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077311 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy.
PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Lung Cancer |
Drug: cisplatin Drug: darbepoetin alfa Drug: dimesna Drug: docetaxel Drug: pegfilgrastim |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Active Control |
Official Title: | A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer |
Study Start Date: | August 2006 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
NOTE: *In both arms, darbepoetin alfa is administered SC on day 1 of each course for hemoglobin ≤ 11 g/dL.
In both arms, treatment repeats every 2 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this study within 18-20 months.
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 of 1 of the following subtypes:
Measurable disease
The following are considered nonmeasurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Antonius A. Miller, MD | Wake Forest University |
Study ID Numbers: | CDR0000350089, CALGB-30303 |
Study First Received: | February 10, 2004 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00077311 |
Health Authority: | United States: Federal Government |
drug/agent toxicity by tissue/organ anemia neutropenia stage IV non-small cell lung cancer stage IIIB non-small cell lung cancer recurrent non-small cell lung cancer |
squamous cell lung cancer large cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer adenosquamous cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Adenocarcinoma, Bronchiolo-Alveolar Darbepoetin alfa Anemia Recurrence Carcinoma Docetaxel Neutropenia |
Adenocarcinoma of lung Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Radiation-Sensitizing Agents Hematinics |
Antineoplastic Agents Therapeutic Uses Hematologic Agents Physiological Effects of Drugs Pharmacologic Actions |