Pancreatic Cancer Research

Clinical trialPhase 1 / Phase 2Completed

Cetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine

Phase I-II Study Evaluating Combined Treatment of Cetuximab and Trastuzumab in Metastatic Pancreatic Cancer Patients Progressing After Gemcitabine Based Chemotherapy.(THERAPY)

NCT00923299↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Finished, no results posted
Phase
Phase 1 / Phase 2
Status
Completed
Study type
Interventional
Start
December 2008
Expected end
March 2011
Enrollment
33 participants
Sites
1
Primary outcomes
Recommended dose of trastuzumab when given with cetuximab (Phase I); Objective response rate as assessed by RECIST criteria (Phase II)
Sponsor
Other
Results posted
No
Last update
16 April 2019

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Brief summary public domain (ClinicalTrials.gov)

RATIONALE: Monoclonal antibodies, such as cetuximab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving cetuximab together with trastuzumab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of trastuzumab when given together with cetuximab and to see how well it works in treating patients with metastatic pancreatic cancer that progressed after previous treatment with gemcitabine.

Detailed description public domain (ClinicalTrials.gov)

OBJECTIVES: Primary * Determine the recommended dose of trastuzumab when given with cetuximab in patients with metastatic pancreatic cancer that progressed after gemcitabine-based chemotherapy. (Phase I) * Evaluate the objective response rate as assessed by RECIST criteria. (Phase II) Secondary * Evaluate the safety profile as assessed by NCI CTCAE v3.0. * Evaluate progression-free survival. * Evaluate overall survival. OUTLINE: This is a multicenter, phase I dose-escalation study of trastuzumab followed by a phase II study. Patients receive cetuximab IV over 1-2 hours and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 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.