Clinical trial NCT01204372: Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma
Official title: Phase II Trial Evaluating the Combination of Gemcitabine, Trastuzumab and Erlotinib as First-line Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Adenocarcinoma
Keywords: Metastatic pancreatic adenocarcinoma
First-line chemotherapy
Combination chemotherapy
Targeted agents
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Disease control rate according to RECIST criteria of the Gemcitabine, Trastuzumab and Erlotinib combination.
timeFrame: Every 8 weeks and at the treatment completion
Secondary outcomes:
measure: Progression free survival
timeFrame: Every 8 weeks and at the treatment completion
measure: Overall survival
timeFrame: Every 8 weeks and at treatment completion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Val d'Aurelle
Study officials:
References:
citation: Assenat E, Mineur L, Mollevi C, Lopez-Crapez E, Lombard-Bohas C, Samalin E, Portales F, Walter T, de Forges H, Dupuy M, Boissiere-Michot F, Ho-Pun-Cheung A, Ychou M, Mazard T. Phase II study evaluating the association of gemcitabine, trastuzumab and erlotinib as first-line treatment in patients with metastatic pancreatic adenocarcinoma (GATE 1). Int J Cancer. 2021 Feb 1;148(3):682-691. doi: 10.1002/ijc.33225. Epub 2020 Sep 2.