Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

NCT ID: NCT00242190

Last Updated: 2010-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2010-02-28

Brief Summary

This study will examine a proposed research treatment which evaluates the addition of oxaliplatin, a chemotherapy agent, to gemcitabine, another chemotherapy agent, and radiation therapy for the treatment of patients with pancreatic cancer. The researchers have already done studies using gemcitabine and radiation therapy together. They want to build on the information they have from this previous research. The researchers believe that the combination chemotherapy with radiation is worth investigating to treat pancreatic cancer. They will use this study to determine what type of side effects occur with this treatment and to assess how effective the treatment is at controlling the cancer.

Conditions

Pancreatic Neoplasms

Keywords

drug therapy; radiotherapy; clinical trial

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

oxaliplatin

Intervention Type: DRUG

gemcitabine

Intervention Type: DRUG

radiation therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
• Patients may have any stage of pancreatic cancer but if metastatic, systemic disease burden should be asymptomatic and small in volume.
• Determination of resectability must be made prior to registration.
• Patients must have an estimated life expectancy of at least 12 weeks and a Zubrod performance status of < = 2.
• Patients must have adequate organ function defined as follows: absolute neutrophil count of > = 1500/mm3, platelets > = 100,000/mm3, serum Cr < = 1.5 mg/dl, bilirubin < 3.0 mg/dl, with relief of biliary obstruction if present (PTC tube or endobiliary stent).
• Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
• Patients of reproductive potential must have agreed to use an effective contraceptive method during participation in this trial and for 6 months after trial.
• Patient must be aware of the investigational nature of the therapy and provide written informed consent.

Exclusion Criteria

• Patients with neuroendocrine tumors are excluded.
• Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
• Patient must not have used any investigational agent in the month before enrollment into the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi-Synthelabo

INDUSTRY

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Mark Zalupski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

UMCC 2003-082

Identifier Type: -

Identifier Source: org_study_id