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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) National Center for Complementary and Alternative Medicine (NCCAM) Radiation Therapy Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005838 |
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. Radiation therapy uses high-energy x-rays to damage tumor cells. AE-941 may help shrink or slow the growth of non-small cell lung cancer cells. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without AE-941 for non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and radiation therapy given with AE-941 to see how well they work compared to combination chemotherapy and radiation therapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: cisplatin Drug: paclitaxel Drug: shark cartilage extract AE-941 Drug: vinorelbine ditartrate Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Multicenter, Open-Ended, Double-Blind, Placebo-Controlled, Phase III Study of AE-941 in Addition to Combined Modality Treatment (Chemotherapy/Radiotherapy) for Locally Advanced Unresectable Non-Small Cell Lung Cancer |
Study Start Date: | March 2000 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to stage (IIIA vs IIIB), type of platinum-based induction chemotherapy to be received (cisplatin and vinorelbine vs carboplatin and paclitaxel), and gender. Patients are randomized to 1 of 2 treatment arms.
All patients receive induction chemotherapy with 1 of the following platinum-based regimens:
Treatment in both arms continues in the absence of unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 756 patients (378 per treatment arm) will be accrued for this study within 36 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed newly diagnosed, untreated, unresectable stage IIIA or stage IIIB non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Charles Lu, MD, SM | M.D. Anderson Cancer Center |
Investigator: | Roy S. Herbst, MD, PhD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000067853, MDA-ID-99303, NCCAM, NCI-T99-0046, RTOG-0270 |
Study First Received: | June 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005838 History of Changes |
Health Authority: | United States: Federal Government |
squamous cell lung cancer large cell lung cancer stage IIIA non-small cell lung cancer |
stage IIIB non-small cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer |
Thoracic Neoplasms Vinblastine Antimitotic Agents Carboplatin Carcinoma Vinorelbine Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Vinblastine Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Vinorelbine Respiratory Tract Diseases Paclitaxel Lung Neoplasms Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |