Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. 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. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I/II Dose Intensification Study Using Three Dimensional Conformal Radiation Therapy And Concurrent Chemotherapy For Patients With Inoperable, Non-Small Cell Lung Cancer|
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Percentage of patients who survive at least 12 months [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Partial organ tolerance doses for lung and esophagus [ Designated as safety issue: Yes ]
- Complete response rate at 3 months after therapy [ Designated as safety issue: No ]
|Study Start Date:||July 2001|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage IIIA or IIIB non-small cell lung cancer. (Phase I) (Closed to accrual as of 01/13/04.)
- Determine the 12-month survival rate in patients treated with this regimen. (Phase II) (Closed to accrual as of 11/27/07.)
- Determine the toxicity of this regimen in these patients.
- Determine the partial organ tolerance doses for the lung and esophagus in patients treated with this regimen.
- Determine the complete response rate in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal radiotherapy.
- Phase I (closed to accrual as of 01/13/04): Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 7-8 weeks. Patients also receive concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.
Cohorts of 7-9 patients receive escalating doses of 3-dimensional conformal radiotherapy until the maximum tolerated dose (MTD) is determined when given in combination with chemotherapy. The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity.
- Phase II: Additional patients are accrued and treated as above at the MTD. At least 3 weeks after completing radiotherapy, patients may receive additional chemotherapy comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once. Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3-5 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 73 patients (27 for phase I [closed to accrual as of 10/28/04] and 46 for phase II) will be accrued for this study within 1-1.5 years.
Show 41 Study Locations
|Study Chair:||Jeffrey Bradley, MD||Mallinckrodt Institute of Radiology at Washington University Medical Center|