Overview

Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
All
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 metastatic pancreatic cancer patients. The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30 min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for three weeks followed by one week of rest. Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and then at 2 mg/kg over 30 min. for the subsequent infusions. Erlotinib will be administered orally at a dose of 100 mg/day from C1D1. The patients will be subjected to research for the EGFR, HER2 and KRAS status.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Treatments:
Erlotinib Hydrochloride
Gemcitabine
Trastuzumab
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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