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Bortezomib, Paclitaxel, and Carboplatin Combined With Radiation Therapy in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

2014-07-23 21:51:53 | BioPortfolio

Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of paclitaxel and carboplatin by making tumor cells more sensitive to the drugs. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving bortezomib, paclitaxel, and carboplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial (phase I closed to accrual as of 09/29/2009) is studying the side effects and best dose of bortezomib, paclitaxel, and carboplatin when given with radiation therapy and to see how well they work in treating patients with stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by surgery.

Description

OBJECTIVES:

Primary

- Determine the maximum tolerated dose of bortezomib, paclitaxel, and carboplatin when administered with fractionated radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer. (Phase I) (closed to accrual as of 09/29/2009)

- Determine the 1-year survival of patients treated with this regimen. (Phase II)

Secondary

- Determine the tolerability of this regimen in these patients. (Phase II)

- Determine the response rate, progression-free survival, and overall survival of patients treated with this regimen. (Phase II)

- Correlate p27 expression in tumor tissue with survival, time to progression, and response in patients treated with this regimen. (Phase II)

OUTLINE: This is a multicenter, phase I (closed to accrual as of 09/29/2009), dose-escalation study of bortezomib, paclitaxel, and carboplatin followed by a phase II study.

- Phase I (closed to accrual as of 09/29/2009): Patients receive bortezomib IV on days 1, 4, 8, and 11. Patients also receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 2. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19. Treatment repeats every 3 weeks up to 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of bortezomib, paclitaxel, and carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

- Phase II: Patients receive bortezomib, paclitaxel, and carboplatin as in phase I at the MTD. Patients also undergo radiotherapy as in phase I.

Patients are followed up periodically for up to 5 years from the time of registration.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I portion of this study within 1.75-2.5 years (closed to accrual as of 09/29/2009). A total of 66 patients will be accrued for the phase II portion of this study within 11 months.

Study Design

Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

bortezomib, carboplatin, paclitaxel, radiation therapy

Location

Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259-5499

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:51:53-0400

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