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Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

Primary Purpose

Pancreatic Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
gemcitabine
radiation therapy
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring drug therapy, radiotherapy, clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan

Outcomes

Primary Outcome Measures

Occurrence of dose limiting toxicity up to three weeks following the second cycle of chemotherapy.

Secondary Outcome Measures

Characterize pattern of responses, progression free survival, and survival after treatment

Full Information

First Posted
October 18, 2005
Last Updated
November 10, 2010
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Sanofi-Synthelabo
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1. Study Identification

Unique Protocol Identification Number
NCT00242190
Brief Title
Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer
Official Title
Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Sanofi-Synthelabo

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
Keywords
drug therapy, radiotherapy, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Type
Procedure
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Occurrence of dose limiting toxicity up to three weeks following the second cycle of chemotherapy.
Secondary Outcome Measure Information:
Title
Characterize pattern of responses, progression free survival, and survival after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Zalupski, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

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