Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

Phase 2

Completed

• Conditions: Metastatic Pancreatic Adenocarcinoma
• Interventions: Drug: Gemcitabine - Trastuzumab - Erlotinib

• Registration Number: NCT01204372
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Primary Completion: 2012-02
• Study Completion: 2016-08
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Gemcitabine - Trastuzumab - Erlotinib	Gemcitabine - Trastuzumab - Erlotinib

Primary Outcome Measures

Name	Time	Method
Disease control rate according to RECIST criteria of the Gemcitabine, Trastuzumab and Erlotinib combination.	Every 8 weeks and at the treatment completion	The tumor evaluation will be based on: * Clinical examination; * TAP CT-scan or MRI; * Tumor marker dosage (CEA and CA 19-9)

Secondary Outcome Measures

Name	Time	Method
Progression free survival	Every 8 weeks and at the treatment completion	The tumor evaluation will be based on: * Clinical examination; * TAP CT-scan or MRI; * Tumor marker dosage
Overall survival	Every 8 weeks and at treatment completion

Trial Locations

Locations (1)

Centre Val d'Aurelle; 🇫🇷 Montpellier, France