Pancreatic Cancer Research

Clinical trialPhase 2Completed

Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer

A Phase I(Limited)/Phase II Study of Oxaliplatin (OXAL) and Gemcitabine (GEMZAR) in Patients With Metastatic Pancreatic Carcinoma

NCT00004190↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Finished, no results posted
Phase
Phase 2
Status
Completed
Study type
Interventional
Start
October 1999
Expected end
June 2003
Enrollment
59 participants
Sites
19
Primary outcomes
overall response rate
Sponsor
Other
Results posted
No
Last update
14 July 2016

These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.

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Brief summary public domain (ClinicalTrials.gov)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and oxaliplatin in treating patients who have refractory locally advanced or metastatic pancreatic cancer.

Detailed description public domain (ClinicalTrials.gov)

OBJECTIVES: I. Determine the safety and tolerability of gemcitabine plus oxaliplatin in patients with refractory metastatic or locally advanced pancreatic cancer (phase I portion of the study closed as of 7/5/00). II. Determine the objective tumor response rate to this combination regimen in this patient population. OUTLINE: This is a dose escalation and efficacy study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 immediately followed by oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks. Patients achieving stable disease, partial response, or regressive disease continue with therapy. Patients achieving complete response for two consecutive evaluations receive an additional 2 courses of therapy. Phase I (closed as of 7/5/00): Cohorts of 3-6 patients receive escalating doses of gemcitabine and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Phase II: Patients receive the MTD of gemcitabine and oxaliplatin as in phase I. Patients are followed every 3 months for 1 year, and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 32-52 patients (12 patients to phase I (phase I closed as of 7/5/00) and 20-40 to phase II) will be accrued for this study within approximately 11-28 months.

Papers 1

The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.