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Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer

NCT00042939 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2023-07-06

Study results available
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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 .

Conditions

Interventions

BIOLOGICAL

cetuximab

Patients received cetuximab intravenous infusions, via infusion pump or syringe pump, once a week for 6 weeks.

DRUG

docetaxel

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.

DRUG

irinotecan hydrochloride

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Barbara A. Burtness, MD · Fox Chase Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-09
Primary Completion
2009-06-30
Completion
2009-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00042939 on ClinicalTrials.gov