Radiation Therapy Plus Paclitaxel in Treating Patients With Nonmetastatic, Unresectable Pancreatic Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients who have nonmetastatic, unresectable pancreatic cancer.
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of External Irradiation (50.4 GY) and Weekly Paclitaxel (Taxol) for Non-Metastatic, Unresectable Pancreatic Cancer|
- To determine the one-year and median survival rates after PXRT [ Designated as safety issue: No ]To determine the one-year and median survival rates after paclitaxel and external beam radiation therapy (PXRT)
- To determine the response rate of PXRT in unresectable pancreatic cancer in a multi-center trial [ Designated as safety issue: No ]
- To evaluate the acute and late treatment morbidity of paclitaxel in a multi-institutional setting [ Designated as safety issue: No ]
- To correlate p53 status with treatment response to PXRT [ Designated as safety issue: No ]
|Study Start Date:||November 1998|
|Study Completion Date:||October 2005|
|Primary Completion Date:||June 2001 (Final data collection date for primary outcome measure)|
Experimental: Pacilitaxel + External Beam Radiation Therapy (PXRT)
Paclitaxel 50 mg/m2 given on Days 1, 8, 15, 22, 29 and 36. Radiation therapy: 50.4 Gy/28 fractions (1.8 Gy per fraction) once a day in 5.5 weeks.
|Drug: paclitaxel Radiation: radiation therapy|
OBJECTIVES: I. Determine the response rate of patients with nonmetastatic, unresectable pancreatic cancer receiving external beam irradiation and weekly paclitaxel. II. Determine the median survival after this treatment in these patients. III. Evaluate the acute and late treatment morbidity of paclitaxel in these patients. IV. Correlate p53 status with treatment response to this treatment in this patient population.
OUTLINE: This is a open label, multicenter study. Patients are highly recommended to undergo laparoscopic surgical staging prior to protocol to exclude peritoneal and hepatic metastases. Patients receive paclitaxel IV over 3 hours weekly for 6 weeks beginning on day 1 followed 1.5 hours later by external beam radiotherapy daily 5 days a week for 5.5 weeks beginning on day 1. All patients are restaged with an abdominal CT scan 6 weeks following completion of chemoradiotherapy. If there is marked response to treatment at this time, curative surgery may be attempted at the discretion of the attending surgeon. Patients are followed every 3 months for 1 year, every 4 months for the second year, every 6 months for years 3-5, and annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients will be accrued into this study over 12 months.