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Paclitaxel, Carboplatin, and High-Dose Radiation Therapy With or Without Vandetanib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

2014-08-27 03:19:24 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving combination chemotherapy together with radiation therapy and vandetanib may kill more tumor cells.

PURPOSE: This randomized phase I/II trial is studying the side effects of giving paclitaxel, carboplatin, and high-dose radiation therapy with or without vandetanib and to see how well it works in treating patients with stage IIIA or stage IIIB non-small cell lung cancer.

Description

OBJECTIVES:

Primary

- To determine the median survival of patients with stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel, carboplatin, and high-dose radiotherapy with or without vandetanib.

Secondary

- To determine the overall response rate and failure-free survival of patients treated with these regimens.

- To determine the feasibility of concurrent vandetanib and chemoradiotherapy as measured by safety and compliance.

- To correlate outcomes (survival, toxicity, and quality of life) with biological parameters.

OUTLINE: This is a multicenter, phase I study followed by a phase II randomized study.

- Phase I: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly and oral vandetanib once daily for 7 weeks. Patients also undergo high-dose radiotherapy once daily 5 days a week for 7 weeks. Beginning in week 11, patients receive consolidation therapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks and oral vandetanib once daily for 6 weeks. Beginning in week 20, patients receive maintenance therapy comprising oral vandetanib once daily for 2 years.

- Phase II: Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive paclitaxel and carboplatin and undergo high-dose radiotherapy as in phase I. Patients also receive oral placebo once daily for 7 weeks. Beginning in week 11, patients receive consolidation therapy comprising paclitaxel and carboplatin as in phase I and oral placebo once daily for 6 weeks. Beginning in week 20, patients receive maintenance therapy comprising oral placebo once daily for 2 years.

- Arm II: Patients receive treatment as in phase I. After completion of study treatment, patients are followed up at 30 days, every 3 months for 2 years, and then every 6 months for 2 years.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

carboplatin, paclitaxel, vandetanib, placebo, radiation therapy

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:24-0400

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Medical and Biotech [MESH] Definitions

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

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