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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00301808 |
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one chemotherapy drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium together with radiation therapy followed by docetaxel works in treating patients with stage III non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: cisplatin Drug: docetaxel Drug: pemetrexed disodium Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer) |
Estimated Enrollment: | 28 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7. Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for 3 courses.
After completion of study therapy, patients are followed at 1 month and periodically thereafter.
PROJECTED ACCRUAL: A total of 28 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:
Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:
Stage IIIA disease, meeting all of the following criteria:
Mediastinal lymph node involvement
Stage IIIB disease, meeting all of the following criteria:
N3 lymph node involvement
Enlarged N3 lymph nodes on CT scan confirmed by PET scan
PATIENT CHARACTERISTICS:
No other concurrent malignancy
No serious medical illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs) 2 days before, during, and for 2 days after pemetrexed disodium administration
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
Sinai-Grace Hospital | Recruiting |
Detroit, Michigan, United States, 48235 | |
Contact: Shirish M Gadgeel 313-576-8753 | |
Veterans Affairs Medical Center - Detroit | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Contact Person 313-576-1000 |
Study Chair: | Shirish M. Gadgeel, MD | Barbara Ann Karmanos Cancer Institute |
Responsible Party: | Barbara Ann Karmanos Cancer Institute ( Shirish M. Gadgeel ) |
Study ID Numbers: | CDR0000461591, WSU-D-2934, WSU-0507002542 |
Study First Received: | March 9, 2006 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00301808 |
Health Authority: | Unspecified |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Folic Acid Pemetrexed Docetaxel Thoracic Neoplasms Non-small cell lung cancer Cisplatin |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |