Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

NCT01204372 | Completed Phase 2 DMC

• 2 other identifiers: GATE 12009-016875-30
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Keywords

Metastatic pancreatic adenocarcinoma; First-line chemotherapy; Combination chemotherapy; Targeted agents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression free survival

  Every 8 weeks and at the treatment completion

• Overall survival

  Every 8 weeks and at treatment completion

Study Arms (1)

Treatment

EXPERIMENTAL

Gemcitabine - Trastuzumab - Erlotinib

Drug: Gemcitabine - Trastuzumab - Erlotinib

Interventions

Gemcitabine - Trastuzumab - Erlotinib DRUG

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Centre Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (1)

• 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.

  PMID: 33405269 RESULT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 17, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: August 1, 2016
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)