Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Trial Evaluating the Combination of Gemcitabine, Trastuzumab and Erlotinib as First-line Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

Conditions
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Metastatic Pancreatic Adenocarcinoma

Intervention / Treatment
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* Drug: Gemcitabine - Trastuzumab - Erlotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Gemcitabine - Trastuzumab - Erlotinib | Drug: Gemcitabine - Trastuzumab - Erlotinib<br>* Treatment will be administered until disease progression, patient's refusal, unacceptable toxicity or investigator's decision. Gemcitabine: IV 1000 mg/m2 on D1, D8, D15, D22, D29, D36 and D43 followed by one week of rest. Subsequently on D1, D8 and D15 followed by one week of rest. Trastuzumab: IV once a week; 4 mg/kg over 90 min. at D1, and 2 mg/kg over 30 min. for the subsequent infusions. Erlotinib: oral route 100 mg/day from C1D1.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | The tumor evaluation will be based on: Clinical examination TAP CT-scan or MRI Tumor marker dosage | Every 8 weeks and at the treatment completion | 
| Overall survival |  | Every 8 weeks and at treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic pancreatic adenocarcinoma, First-line chemotherapy, Combination chemotherapy, Targeted agents