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Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

NCT ID: NCT00456599

Last Updated: 2015-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2013-01-31

Brief Summary

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This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Detailed Description

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This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites. They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxaliplatin & gemcitabine with radiation

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Group Type EXPERIMENTAL

gemcitabine

Intervention Type DRUG

Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.

oxaliplatin

Intervention Type DRUG

Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.

Radiation

Intervention Type PROCEDURE

The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.

Interventions

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gemcitabine

Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.

Intervention Type DRUG

oxaliplatin

Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.

Intervention Type DRUG

Radiation

The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.

Intervention Type PROCEDURE

Other Intervention Names

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Gemzar Eloxatin RT

Eligibility Criteria

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Inclusion Criteria

* Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
* Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration.
* Patients must have an expected 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, total 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 must be aware of the investigational nature of the therapy and provide written informed consent.
* Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
* Patients must not have used any investigational agent in the month before enrollment into the study.

Exclusion Criteria

* Patients with neuroendocrine tumors are excluded.
* Patients with preexisting peripheral neuropathy \> grade 2 are ineligible.
* Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Zalupski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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Kim EJ, Ben-Josef E, Herman JM, Bekaii-Saab T, Dawson LA, Griffith KA, Francis IR, Greenson JK, Simeone DM, Lawrence TS, Laheru D, Wolfgang CL, Williams T, Bloomston M, Moore MJ, Wei A, Zalupski MM. A multi-institutional phase 2 study of neoadjuvant gemcitabine and oxaliplatin with radiation therapy in patients with pancreatic cancer. Cancer. 2013 Aug 1;119(15):2692-700. doi: 10.1002/cncr.28117. Epub 2013 May 29.

Reference Type RESULT
PMID: 23720019 (View on PubMed)

Other Identifiers

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HUM 4531

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2006.025

Identifier Type: -

Identifier Source: org_study_id

NCT00426738

Identifier Type: -

Identifier Source: nct_alias