NCT00032032

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

Phase I/II Study Of Concurrent Chemotherapy And Escalating Doses Of Radiotherapy (RT) For Unresectable Non-Small Cell Lung Cancer (NSCLC) Using A New RT Paradigm

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of radiotherapy in combination with carboplatin and paclitaxel in patients with unresectable non-small cell lung cancer. * Determine the 2-year survival of patients treated with this regimen. * Determine the progression-free local control rate in patients treated this regimen. * Determine the tolerability of this regimen in these patients. * Assess the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients undergo radiotherapy\* once daily 5 days a week for 7 weeks and 2 days (a total of 37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. NOTE: \*No prophylactic nodal radiotherapy is administered Cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated at that dose level in the phase II portion of the study. Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, once during the last week of radiotherapy, and then every 3 months for 2 years. Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	paclitaxel
RADIATION	radiation therapy

Timeline

• Start date: 2002-05-01
• Primary completion: 2008-01-01
• Completion: 2010-01-01
• First posted: 2003-01-27
• Last updated: 2016-12-01

Locations

51 sites across 1 country: United States