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

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: cetuximab; Drug: trastuzumab

• Registration Number: NCT00923299
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Primary Completion: 2010-04
• Study Completion: 2011-03
• Status Verified: 2017-08
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cetuximab, trastuzumab	cetuximab	-
cetuximab, trastuzumab	trastuzumab	-

Primary Outcome Measures

Name	Time	Method
Recommended dose of trastuzumab when given with cetuximab (Phase I)	15 days	From baseline to the end of treatment
Objective response rate as assessed by RECIST criteria (Phase II)	Approximately 8 weeks	From baseline to the end of treatment

Secondary Outcome Measures

Name	Time	Method
Overall survival	Approximately 36 months	From baseline to the end of study
Progression-free survival	Approximately 36 months	From baseline to the end of study

Trial Locations

Locations (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France