Clinical trial NCT00242190: Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer
Official title: Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Neoplasms
Keywords: drug therapy
radiotherapy
clinical trial
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Sanofi-Synthelabo
First posted: 2005-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Occurrence of dose limiting toxicity up to three weeks following the second cycle of chemotherapy.
Secondary outcomes:
measure: Characterize pattern of responses, progression free survival, and survival after treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mark Zalupski, MD
role: PRINCIPAL_INVESTIGATOR
References: