Pemetrexed and Cisplatin or Paclitaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Summary
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether pemetrexed is more effective when given together with cisplatin or paclitaxel in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying pemetrexed to compare how well it works when given together with cisplatin or paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Description
OBJECTIVES:
Primary
- To compare the survival of patients with ERCC1-positive or -negative stage IIIB or IV non-small cell lung cancer treated with pemetrexed disodium in combination with cisplatin vs paclitaxel.
Secondary
- To compare the progression-free survival, response rate, and quality of life of patients treated with these regimens.
- To investigate whether the effect of treatment differs according to histology, gender, and performance status.
- To undertake a cost-effectiveness analysis based on the ERCC1 status of these patients.
OUTLINE: This is a multicenter study.
Patients are stratified according to disease stage (IIIB vs IV), histology (squamous vs non-squamous), smoking history (ever vs never smoker), and ERCC1 status (negative vs positive). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive pemetrexed disodium IV over 10 minutes and paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo quality of life assessment at baseline, prior to each course of treatment, at 21-28 days after completion of treatment, and then at 6, 12, 18, and 24 months.
After completion of study treatment, patients are followed monthly for 1 year and then every 2 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Study Design
Allocation: Randomized, Primary Purpose: Treatment
Conditions
Lung Cancer
Intervention
cisplatin, paclitaxel, pemetrexed disodium
Status
Not yet recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00801736
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cisplatin
An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.
Lung Neoplasms
Tumors or cancer of the LUNG.
Carcinoma, Bronchogenic
Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.
Tumor Suppressor Protein P53
Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.
Carcinoma, Non-small-cell Lung
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
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