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