At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic adenocarcinoma of the pancreas
- ✓At least one unidimensionally measurable lesion (primary or metastatic)
- ✓Tumor tissue available for EGFR testing via fine needle aspiration, core biopsy, or open biopsy
- ✓ECOG performance status 0–1
- ✕Prior chemotherapy
- ✕History of uncontrolled arrhythmias
- ✕History of congestive heart failure
- ✕History of uncontrolled angina pectoris
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Irinotecan/Docetaxel for Advanced Pancreatic Cancer, With Randomization Between Irinotecan/Docetaxel and Irinotecan/Docetaxel Plus C225 a Monoclonal Antibody to the Epidermal Growth Factor Receptor (EGF-r)
In Brief
A Phase 2 clinical trial evaluating cetuximab, docetaxel, and 1 other intervention for Pancreatic Cancer. Completed, enrolled 94 participants.
Detailed Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells. PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer .
Study Details
Timeline
Interventions
Patients received cetuximab intravenous infusions, via infusion pump or syringe pump, once a week for 6 weeks.
Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was diluted in 100-150 ml of infusion solution.
After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest.