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

NCT00068575 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2012-02-15

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa may interfere with the growth of the tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and interferon alfa with radiation therapy after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and interferon alfa together with radiation therapy works in treating patients who have undergone surgery for stage I, stage II, or stage III pancreatic cancer.

Conditions

Interventions

BIOLOGICAL

Recombinant Interferon Alfa

3 million units subcutaneously every other day (Monday, Wednesday and Friday) during Days 1-19 and 29-45, for 6 1/2 weeks totaling 17 doses.

DRUG

Cisplatin

30 mg/m\^2 IV over 60 minutes on days 1, 8, 15, 29, 36, 43 - weekly for total 6 doses, during 5 1/2 weeks radiation therapy.

DRUG

Fluorouracil

175 mg/m\^2/day continuous infusion over 6 1/2 weeks for total 3 courses: Days 1-19 and 29-45, Days 71-108 and Days 127-168.

RADIATION

Radiation Therapy

External beam radiation on days 1-19 and days 29-45, 9 day treatment break on day 20.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Schering-Plough

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Peter W. Pisters, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00068575 on ClinicalTrials.gov