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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456599
• Other study ID #: UMCC 2006.025
• Secondary ID: HUM 4531
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2007
• Last updated: November 4, 2015
• Start date: April 2007
• Est. completion date: January 2013

Study information

• Verified date: November 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.
• oxaliplatin
Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.

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

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	Ohio State University	Columbus	Ohio

Sponsors (5)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	Johns Hopkins University, Ohio State University, Princess Margaret Hospital, Canada, Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 gemci — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-year Disease Free Survival.	The percent of patients alive and disease-free at two years.	two years	No
Secondary	Time to Treatment Failure	Median time for disease recurrence after surgery.	2 years	No
Secondary	Overall Survival	Percent overall survival was calculated for all evaluable patients.	5 years	No