Metastatic Pancreatic Adenocarcinoma
Conditions
Keywords
Metastatic pancreatic adenocarcinoma, First-line chemotherapy, Combination chemotherapy, Targeted agents
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.
Interventions
DRUGGemcitabine - Trastuzumab - Erlotinib
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.
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
France
Outcome results
None listed