Back to resultsCetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine (THERAPY)
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
cetuximab
trastuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage IV pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic adenocarcinoma of the pancreas
- Progressed after first-line or adjuvant gemcitabine-based chemotherapy
- Measurable disease as assessed by RECIST criteria
- No known brain metastasis or symptomatic carcinomatous leptomeningitis
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 2.5 times ULN
- ALT/AST ≤ 5 times ULN
- LVEF ≥ 55%
- Not pregnant or nursing
- Fertile patients must use effective contraception
No significant comorbidities, including any of the following:
- Cardiovascular disease
- Documented history of congestive heart failure
- Uncontrolled, high-risk arrhythmia
- Angina pectoris requiring treatment
- Clinically significant valvular disease
- Evidence of transmural myocardial infarction by ECG
- Uncontrolled hypertension
- Active bleeding
- Clinically significant active infection
- Severe dyspnea at rest
- Oxygen-dependency
- No other malignancy except basal cell carcinoma of the skin
- No severe hypersensitivity to cetuximab or trastuzumab
- No medical or psychological condition that would preclude study completion or giving informed consent
- No legal incapacity or limited legal capacity
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior cetuximab or trastuzumab
- No other concurrent experimental drugs or anticancer therapy
Sites / Locations
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
cetuximab, trastuzumab
Arm Description
Outcomes
Primary Outcome Measures
Recommended dose of trastuzumab when given with cetuximab (Phase I)
From baseline to the end of treatment
Objective response rate as assessed by RECIST criteria (Phase II)
From baseline to the end of treatment
Secondary Outcome Measures
Progression-free survival
From baseline to the end of study
Overall survival
From baseline to the end of study
Full Information
NCT ID
NCT00923299
First Posted
June 17, 2009
Last Updated
April 12, 2019
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT00923299
Brief Title
Cetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine
Acronym
THERAPY
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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage IV pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cetuximab, trastuzumab
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
trastuzumab
Intervention Description
Two dose levels of trastuzumab will be evaluated for Phase 1:
Level 1: a loading dose of 3 mg/kg as a 90-minute intravenous infusion at J1S1 and then 1.5 mg/kg as a 30-minute intravenous infusion for all subsequent weekly administrations;
Level 2: a loading dose of 4 mg/kg as a 90-minute intravenous infusion at J1S1 and then 2 mg/kg as a 30-minute intravenous infusion for all subsequent weekly administrations.
Primary Outcome Measure Information:
Title
Recommended dose of trastuzumab when given with cetuximab (Phase I)
Description
From baseline to the end of treatment
Time Frame
15 days
Title
Objective response rate as assessed by RECIST criteria (Phase II)
Description
From baseline to the end of treatment
Time Frame
Approximately 8 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
From baseline to the end of study
Time Frame
Approximately 36 months
Title
Overall survival
Description
From baseline to the end of study
Time Frame
Approximately 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic adenocarcinoma of the pancreas
Progressed after first-line or adjuvant gemcitabine-based chemotherapy
Measurable disease as assessed by RECIST criteria
No known brain metastasis or symptomatic carcinomatous leptomeningitis
PATIENT CHARACTERISTICS:
WHO performance status 0-1
Life expectancy ≥ 3 months
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Total bilirubin ≤ 2.5 times ULN
ALT/AST ≤ 5 times ULN
LVEF ≥ 55%
Not pregnant or nursing
Fertile patients must use effective contraception
No significant comorbidities, including any of the following:
Cardiovascular disease
Documented history of congestive heart failure
Uncontrolled, high-risk arrhythmia
Angina pectoris requiring treatment
Clinically significant valvular disease
Evidence of transmural myocardial infarction by ECG
Uncontrolled hypertension
Active bleeding
Clinically significant active infection
Severe dyspnea at rest
Oxygen-dependency
No other malignancy except basal cell carcinoma of the skin
No severe hypersensitivity to cetuximab or trastuzumab
No medical or psychological condition that would preclude study completion or giving informed consent
No legal incapacity or limited legal capacity
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior cetuximab or trastuzumab
No other concurrent experimental drugs or anticancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ychou, MD, PhD
Organizational Affiliation
Institut du Cancer de Montpellier - Val d'Aurelle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25918250
Citation
Assenat E, Azria D, Mollevi C, Guimbaud R, Tubiana-Mathieu N, Smith D, Delord JP, Samalin E, Portales F, Larbouret C, Robert B, Bibeau F, Bleuse JP, Crapez E, Ychou M, Pelegrin A. Dual targeting of HER1/EGFR and HER2 with cetuximab and trastuzumab in patients with metastatic pancreatic cancer after gemcitabine failure: results of the "THERAPY"phase 1-2 trial. Oncotarget. 2015 May 20;6(14):12796-808. doi: 10.18632/oncotarget.3473.
Results Reference
result
Learn more about this trial
Cetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine
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