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Completed

NCT Number: NCT00242190

Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxaliplatin

Drug

Gemcitabine

Drug

Radiation Therapy

Procedure

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

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • Sanofi-Synthelabo

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2010
First posted
Oct 19, 2005
Registry last updated
Nov 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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