Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over NCI MDA-ID-02040 NCT00068575

Objectives

Primary

1. Determine the overall survival of patients with previously resected pancreatic adenocarcinoma treated with postoperative cisplatin, interferon alfa, fluorouracil, and concurrent radiotherapy.
2. Determine the toxic effects of this regimen in these patients.

Secondary

1. Determine the disease-specific, biochemical failure-free, and symptom/treatment-free survival of patients treated with this regimen.
2. Determine the quality of life of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed pancreatic adenocarcinoma of the pancreatic head or uncinate process
  • Stage I, II, or III



• Completely resected disease (R0 or R1)
  • Postoperative CA 19-9 less than 100
  • Study treatment must begin within 12 weeks of surgery



• Postoperative CT scan without evidence of radiographically definable residual primary/metastatic disease or clinically significant postsurgical changes

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC greater than 3,000/mm³
• Absolute neutrophil count greater than 1,500/mm³
• Platelet count greater than 75,000/mm³
• Hemoglobin greater than 9.0 g/dL

Hepatic

• Not specified

Renal

• Creatinine less than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• Bilateral renal function by excretory urogram (IVP) or abdominal CT scan OR at least 2/3 of 1 functioning kidney must be able to be shielded from the radiotherapy beam

Cardiovascular

• No significant cardiovascular disease
• No unstable angina
• No congestive heart failure

Pulmonary

• No severe pulmonary disease

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Prior history of non-pancreatic malignancy allowed at the discretion of the study chair provided patient is free of the primary cancer
• No concurrent acute infection

Expected Enrollment

A total of 44 patients will be accrued for this study.

Outcomes

Overall survival
Toxicity

Disease-specific survival
Biochemical failure-free survival
Symptom and treatment-free survival
Qualitiy of life

Outline

• Chemoradiotherapy: Patients receive fluorouracil IV continuously and interferon alfa subcutaneously 3 times per week (total of 17 doses) on days 1-19 and 29-45 and cisplatin IV over 6 hours on days 1, 8, 15, 29, 36 and 43. Patients also undergo concurrent radiotherapy once daily, 5 days a week in weeks 1-3 and 5-7 (28 fractions).



• Post-chemoradiotherapy fluorouracil: Patients receive fluorouracil IV continuously on days 71-108 and 127-168.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Peter Pisters, MD, Protocol chair		Ph: 713-794-1572; 800-392-1611

U.S.A.
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245

Registry Information
Official Title		Phase II Trial Of Postoperative Cisplatin, Interferon, 5-FU With XRT For Patients With Resected Pancreatic Adenocarcinoma
Trial Start Date		2003-05-31
Registered in ClinicalTrials.gov		NCT00068575
Date Submitted to PDQ		2003-07-28
Information Last Verified		2007-07-03
NCI Grant/Contract Number		CA16672

Back to Top