Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

Metastatic Pancreatic Adenocarcinoma Clinical Trial

— GATE 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204372
• Other study ID #: GATE 1
• Secondary ID: 2009-016875-30
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2010
• Last updated: August 16, 2017
• Start date: June 2010
• Est. completion date: August 2016

Study information

• Verified date: August 2017
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 2016
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma

Intervention

Drug:
• Gemcitabine - 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.

Locations

Country	Name	City	State
France	Centre Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall survival		Every 8 weeks and at treatment completion