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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Pancreatic Adenocarcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease control rate according to RECIST criteria of the Gemcitabine, Trastuzumab and Erlotinib combination.

Outcome Description:

The tumor evaluation will be based on: Clinical examination TAP CT-scan or MRI Tumor marker dosage (CEA and CA 19-9)

Outcome Time Frame:

Every 8 weeks and at the treatment completion

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GATE 1

NCT ID:

NCT01204372

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Metastatic Pancreatic Adenocarcinoma
  • Metastatic pancreatic adenocarcinoma
  • First-line chemotherapy
  • Combination chemotherapy
  • Targeted agents
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

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