Cetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine (THERAPY)
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|ClinicalTrials.gov Identifier: NCT00923299|
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : April 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: cetuximab Drug: trastuzumab||Phase 1 Phase 2|
- 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)
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Study Evaluating Combined Treatment of Cetuximab and Trastuzumab in Metastatic Pancreatic Cancer Patients Progressing After Gemcitabine Based Chemotherapy.(THERAPY)|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||March 2011|
Cetuximab at the initial dose of 400 mg/m² (J1S1) as a 2-hour infusion and then at the 250 mg/m² dose as a 1-hour infusion in subsequent weeks.
Two dose levels of trastuzumab will be evaluated for Phase 1:
- Recommended dose of trastuzumab when given with cetuximab (Phase I) [ Time Frame: 15 days ]From baseline to the end of treatment
- Objective response rate as assessed by RECIST criteria (Phase II) [ Time Frame: Approximately 8 weeks ]From baseline to the end of treatment
- Progression-free survival [ Time Frame: Approximately 36 months ]From baseline to the end of study
- Overall survival [ Time Frame: Approximately 36 months ]From baseline to the end of study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923299
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Principal Investigator:||Marc Ychou, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|