Status:
COMPLETED
Cetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 hel...
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. (Pha...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00923299
Start Date
December 1 2008
End Date
March 1 2011
Last Update
April 16 2019
Active Locations (1)
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1
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298