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Gemcitabine Plus Carboplatin or Cisplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-small Cell Lung Cancer

2014-08-27 03:58:20 | BioPortfolio

Summary

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.

PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine plus carboplatin with that of gemcitabine plus cisplatin in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Description

OBJECTIVES: I. Determine the response rates of gemcitabine and carboplatin vs gemcitabine and cisplatin in patients with stage IIIB, IV, or recurrent non-small cell lung cancer. II. Determine the toxicity of these two regimens in this patient population. III. Determine the time to progression and one year survival of these patients on these regimens.

OUTLINE: This is a randomized study. Patients are stratified by stage of disease and gender. Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, followed by carboplatin over 60 minutes on day 1. Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, followed by cisplatin IV over 60 minutes on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months, every two months for 6 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 1 year.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

carboplatin, cisplatin, gemcitabine hydrochloride

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:20-0400

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Medical and Biotech [MESH] Definitions

A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.

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.

Tumors or cancer of the LUNG.

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

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.

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