Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

NCT00242190 | Completed Phase 1

• 1 other identifier: UMCC 2003-082
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms

Keywords

drug therapy; radiotherapy; clinical trial

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

oxaliplatin DRUG

gemcitabine DRUG

radiation therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Sanofi-Synthelabo: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; Gemcitabine; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• Mark Zalupski, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2005
• First Posted: October 19, 2005
• Study Start: June 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: February 1, 2010
• Last Updated: November 15, 2010

Record last verified: 2010-11

Locations

US (1)