Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

Pancreatic Neoplasms Clinical Trial

Official title:

Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242190
• Other study ID #: UMCC 2003-082
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 18, 2005
• Last updated: November 10, 2010
• Start date: June 2004
• Est. completion date: February 2010

Study information

• Verified date: November 2010
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2010
• Est. primary completion date: March 2006
• 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 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• oxaliplatin

• gemcitabine

Procedure:
• radiation therapy

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	Sanofi-Synthelabo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of dose limiting toxicity up to three weeks following the second cycle of chemotherapy.
Secondary	Characterize pattern of responses, progression free survival, and survival after treatment