drugset / Trial / NCT00323583

Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer

NCT00323583

Phase 2 Unknown 80 enrolled Seattle Cancer Treatment and Wellness Center
Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, oxaliplatin, leucovorin and 5-fluoruracil, work in different ways separately and in combination to stop tumor cells from dividing so they stop growing or die. The use of metronomic dosing of chemotherapy minimizes side effects and increases efficacy by anti-angiogenic effects. The pilot study demonstrated promising responses in all patients. It is not yet known how effective this drug and dosing combination is in treating advanced pancreatic cancer. PURPOSE: This non-randomized phase II trial is studying giving weekly doses of paclitaxel, oxaliplatin, leucovorin and 5-fluorouracil together as second or third-line therapy in treating patient with locally advanced unresectable or metastatic adenocarcinoma of the pancreas following demonstrated progression after first-line gemcitabine.

Timeline

Start
2006-05
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Leucovorin Small molecule 20 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 50 mg/m2 Intravenous
Subject Paclitaxel Small molecule 60 mg/m2 Intravenous
Subject fluorouracil Small molecule 425 mg/m2 Intravenous
Background Calcium carbonate Other / unclassified 1 g Intravenous
Background Glutathione Peptide 1500 mg/m2 Intravenous
Background Magnesium Sulfate Other / unclassified 1 g Intravenous