Status:
COMPLETED
Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Metastatic Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line chemotherapy in metasta...
Eligibility Criteria
Inclusion
- Metastatic pancreatic adenocarcinoma confirmed by histology
- Tumor sample available
- Measurable lesion according to RECIST criteria
- Performance status ≥ 1
- Life expectancy \> 3 months
- Hematology: Hb ≥ 9g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
- Renal function: creatinine ≤ 1.5 x ULN
- Hepatic function: total bilirubin ≤ 2.5 x ULN, transaminases ≤ 5 x ULN
- Left ventricular ejection fraction (LVEF) ≥ 50%
- At least a 6-month delay between the end of any previous gemcitabine-based chemotherapy and diagnosis of metastases
- Social security
- Informed consent obtained prior to inclusion.
Exclusion
- Non metastatic advanced local disease
- Presence of cerebral metastases or symptomatic leptomeningeal carcinomatosis
- Others cancers except BBC and cervical cancer receiving curative treatment
- No previous treatment by Erlotinib or Trastuzumab
- Known severe hypersensitivity to Erlotinib, Trastuzumab, murine proteins or Gemcitabine
- Presence of significant co-morbidities
- Concomitant treatment with other experimental products or other anticancer therapies
- Breastfeeding or pregnant female, or patient of reproductive age not using adequate contraception
- Legal incapacity or limited legal incapacity
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01204372
Start Date
June 1 2010
End Date
August 1 2016
Last Update
August 21 2017
Active Locations (1)
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1
Centre Val d'Aurelle
Montpellier, France, 34298