Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma (GATE 1)

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase: Completed; Phase 2

Conditions: Metastatic Pancreatic Adenocarcinoma

Treatments: Drug: Gemcitabine - Trastuzumab - Erlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT01204372

2009-016875-30 (EudraCT Number)

GATE 1

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Treatment

Experimental group

Description:

Gemcitabine - Trastuzumab - Erlotinib

Treatment:

Drug: Gemcitabine - Trastuzumab - Erlotinib