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A Phase II Trial of Pancreaticoduodenectomy Plus Postoperative Cisplatin, Interferon Alfa-2b, and 5-FU Combined With Radiation Treatment for Patients With Resected Pancreatic Adenocarcinoma

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Phase II Trial of Pancreaticoduodenectomy Plus Postoperative Cisplatin, Interferon Alfa-2b, and 5-FU Combined With Radiation Treatment for Patients With Resected Pancreatic Adenocarcinoma



- Determine the overall survival of patients with previously resected pancreatic
adenocarcinoma treated with postoperative cisplatin, interferon alfa, fluorouracil, and
concurrent radiotherapy.

- Determine the toxic effects of this regimen in these patients.


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

- Determine the quality of life of patients treated with this regimen.


- Chemoradiotherapy: Patients receive fluorouracil intravenous (IV) continuously and
interferon alfa subcutaneously (SQ) 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

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

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

Inclusion Criteria:

1. Biopsy proven completely resected (R0 or R1) pancreatic adenocarcinoma of the
pancreatic head or uncinate process [American Joint Committee on Cancer (AJCC) Stage
I-III]. Surgery (pancreaticoduodenectomy) may be performed at M. D. Anderson Cancer
Center or prior to referral to M. D. Anderson Cancer Center. Protocol treatment must
begin within 12 weeks of surgery.

2. Postoperative (pre-treatment) computed tomography (CT) scan without evidence of
radiographically defineable residual primary/metastatic disease or clinically
significant post-surgical changes.

3. Staging studies completed within three weeks +/- 3 days of protocol registration.

4. Hemoglobin (Hb) >9.0 g/%, White Blood Count (WBC) >3,000 cells/mm3 (Absolute
neutrophil count (ANC)>1,500 cells/mm3), platelets >75,000 cells/mm3.

5. Postoperative serum calcium (CA) 19-9 < 100.

6. Performance status: Zubrod 0 or 1.

7. Creatinine £1.5 mg/dL and calculated or measured creatinine clearance (CrCl) of 60
ml/min or greater by the following formula: Creatinine clearance rate (CrCl) = (140 -
age) * Weight (kg) * 0.85 (female) OR * 1.00 (male) 72 * serum creatinine

8. Patients should have bilateral renal function, as determined on excretory urogram
(IVP) or abdominal CT, or ³ 2/3 of one functioning kidney must be able to be shielded
from the radiation beam.

9. No acute infections at the time of therapy initiation.

10. Women of childbearing potential must agree to practice adequate contraception and to
refrain from breast feeding, as specified in the informed consent.

11. Patients must sign a study-specific consent form, which is attached to this protocol.

12. Patients with a prior history of non-pancreatic malignancy who are free of disease
from their primary cancer may be eligible at the discretion of the study chair.

Exclusion Criteria:

1. Residual (clinical or CT definable) metastatic or incompletely resected local

2. Patients with positive peritoneal cytology (for adenocarcinoma) detected at
laparotomy for pancreaticoduodenectomy or as part of prior laparoscopic assessment of
peritoneal cytology.

3. Patients with a history of hypersensitivity to interferon alfa-2b.

4. Patients with significant cardiovascular disease, such as unstable angina or
congestive heart failure.

5. Pregnancy or breastfeeding.

6. Patients with severe pulmonary disease.

7. Children under the age of 18 are excluded (as the disease is rare and toxicity
profile of this regimen untested in pediatric patients).

8. Presence or history of severe depression.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median Overall Survival (OS)

Outcome Description:

Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death.

Outcome Time Frame:

Participants followed till disease progression or death (approximately 6 years)

Safety Issue:


Principal Investigator

Peter W. Pisters, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

December 2010

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms



M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009