Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer
This study has been completed.
Sponsor:
University of Michigan Cancer Center
Collaborator:
Sanofi-Synthelabo
Information provided by:
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00242190
First received: October 18, 2005
Last updated: November 10, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Neoplasms |
Drug: oxaliplatin Drug: gemcitabine Procedure: radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by University of Michigan Cancer Center:
Primary Outcome Measures:
- Occurrence of dose limiting toxicity up to three weeks following the second cycle of chemotherapy.
Secondary Outcome Measures:
- Characterize pattern of responses, progression free survival, and survival after treatment
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2004 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242190
Locations
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
Sponsors and Collaborators
University of Michigan Cancer Center
Sanofi-Synthelabo
Investigators
| Principal Investigator: | Mark Zalupski, MD | University of Michigan |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00242190 History of Changes |
| Other Study ID Numbers: | UMCC 2003-082 |
| Study First Received: | October 18, 2005 |
| Last Updated: | November 10, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan Cancer Center:
|
drug therapy radiotherapy clinical trial |
Additional relevant MeSH terms:
|
Neoplasms Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Oxaliplatin Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 21, 2013