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Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer


Phase 2
18 Years
75 Years
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer


Inclusion Criteria:



- Histologically confirmed pancreatic cancer.

- Measurable disease.

- Absence of ascites or obstructive jaundice.

- ECOG Performance Status 0-2.

- Adequate liver kidney and bone marrow function.

- Written informed consent.

Exclusion Criteria:

- Chronic diarrheic syndrome.

- Uncontrolled brain metastases after radiation.

- Liver infiltration over 50%.

- Peripheral neuropathy ≥ 2.

- No second primary malignancy within the past 5 years, except non-melanomas skin
cancer or in situ carcinoma of the cervix.

- No active uncontrolled infection.

- Active cardiac disease : unstable angina or onset of angina within last 3 months,
myocardial infarction within 6 months, congestive heart failure > class II, cardiac
ventricular arrhythmias requiring anti-arrhythmic therapy.

- Women who are pregnant or lactating.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

1 year survival

Safety Issue:

No

Principal Investigator

Vassilis Georgoulias, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Dep of Medical Oncology

Authority:

Greece: National Organization of Medicines

Study ID:

CT/06.13

NCT ID:

NCT00564720

Start Date:

December 2006

Completion Date:

March 2011

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

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