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Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-Small Cell Lung Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.

PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer.

Description

OBJECTIVES:

- Compare the survival and time to progression of patients with stage IIIA or IIIB non-small cell lung cancer when treated with carboplatin, paclitaxel, and chemoradiotherapy with or without thalidomide.

- Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two groups.

- Determine whether the inactivation of p16, DAP-kinase, MGMT, or TIMP-3 genes can be used to predict survival in these patients treated with this regimen.

- Determine whether the detection of a methylation biomarker in serum can be used to predict survival in these patients treated with this regimen.

OUTLINE: This is a randomized study. Patients are stratified according to disease histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and time of randomization (before addition of chemoradiotherapy vs after). Patients are randomized to one of two treatment arms.

- Arm I: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 15-30 minutes on days 1 and 22. Treatment continues every 22 days in the absence of unacceptable toxicity or disease progression.

- Arm II: Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral thalidomide and oral low-dose aspirin daily beginning on day 1 for up to 24 months in the absence of disease progression.

Beginning between days 43-50, patients in both arms with stable or responding disease receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30 minutes once weekly for 6 weeks and radiotherapy 5 days a week for 6 weeks. Arm II patients continue oral thalidomide.

Patients are followed every 2 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 588 patients will be accrued for this study within 7 years.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

carboplatin, paclitaxel, thalidomide, radiation therapy

Location

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Ft. Smith
Arkansas
United States
72903

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

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

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Medical and Biotech [MESH] Definitions

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A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppresive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.

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Drugs used to protect against ionizing radiation. They are usually of interest for use in radiation therapy but have been considered for other, e.g. military, purposes.

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