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

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

gemcitabine

oxaliplatin

Radiation

About this trial

This is an interventional treatment trial for Pancreatic Cancer

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 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.

Sites / Locations

Johns Hopkins University
University of Michigan
Ohio State University
Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxaliplatin & gemcitabine with radiation

Arm Description

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

Outcomes

Primary Outcome Measures

Two-year Disease Free Survival.

The percent of patients alive and disease-free at two years.

Secondary Outcome Measures

Time to Treatment Failure

Median time for disease recurrence after surgery.

Overall Survival

Percent overall survival was calculated for all evaluable patients.

Full Information

NCT ID

NCT00456599

First Posted

April 4, 2007

Last Updated

November 4, 2015

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Sanofi, Johns Hopkins University, Princess Margaret Hospital, Canada, Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT00456599

Brief Title

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

Official Title

A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Sanofi, Johns Hopkins University, Princess Margaret Hospital, Canada, Ohio State University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxaliplatin & gemcitabine with radiation

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Other Intervention Name(s)

Eloxatin

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Radiation

Other Intervention Name(s)

Intervention Description

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

Primary Outcome Measure Information:

Title

Two-year Disease Free Survival.

Description

The percent of patients alive and disease-free at two years.

Time Frame

two years

Secondary Outcome Measure Information:

Title

Time to Treatment Failure

Description

Median time for disease recurrence after surgery.

Time Frame

2 years

Title

Overall Survival

Description

Percent overall survival was calculated for all evaluable patients.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

23720019

Citation

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.

Results Reference

result

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

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