Radiation Therapy Plus Paclitaxel in Treating Patients With Nonmetastatic, Unresectable Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: paclitaxel; Radiation: radiation therapy

• Registration Number: NCT00003591
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1998-11
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-06
• Study First Submitted QC: 2004-09-10
• Study First Posted: 2004-09-13
• Study Completion: 2005-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pacilitaxel + External Beam Radiation Therapy (PXRT)	paclitaxel	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.
Pacilitaxel + External Beam Radiation Therapy (PXRT)	radiation therapy	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.

Primary Outcome Measures

Name	Time	Method
To determine the one-year and median survival rates after PXRT		To determine the one-year and median survival rates after paclitaxel and external beam radiation therapy (PXRT)

Secondary Outcome Measures

Name	Time	Method
To correlate p53 status with treatment response to PXRT
To determine the response rate of PXRT in unresectable pancreatic cancer in a multi-center trial
To evaluate the acute and late treatment morbidity of paclitaxel in a multi-institutional setting

Trial Locations

Locations (234)

Veterans Affairs Medical Center - Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Huntsville Hospital System; 🇺🇸 Huntsville, Alabama, United States

Urology Associates - Mobile AL; 🇺🇸 Mobile, Alabama, United States

MBCCOP - University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Alabama Oncology, LLC; 🇺🇸 Montgomery, Alabama, United States

Radiation Oncology Associates of West Alabama; 🇺🇸 Tuscallosa, Alabama, United States

Providence Cancer Therapy Center; 🇺🇸 Anchorage, Alaska, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Providence Saint Joseph Medical Center - Burbank; 🇺🇸 Burbank, California, United States

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