Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer.

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

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: Gemcitabine
* Drug: Erlotinib
* Drug: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>GEM/TAR | Drug: Gemcitabine<br>* Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles<br>* Other names: Gemzar;Drug: Erlotinib<br>* Erlotinib 100 mg by mouth (p.o.), daily until disease progression<br>* Other names: Tarceva;|
| Experimental: 2<br>GEM/OX/TAR | Drug: Gemcitabine<br>* Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles<br>* Other names: Gemzar;Drug: Erlotinib<br>* Erlotinib 100 mg by mouth (p.o.), daily until disease progression<br>* Other names: Tarceva;Drug: Oxaliplatin<br>* Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles<br>* Other names: Eloxatin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 1 year survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free interval |  | 1 year | 
| Response rate |  | Objective responses confirmed by CT or MRI on 3rd and 6th cycle | 
| Toxicity profile |  | Toxicity assessment on each chemotherapy cycle | 
| Symptoms improvement |  | Assessment every two cycles |