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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

GEM/TAR

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles

Erlotinib

Intervention Type DRUG

Erlotinib 100 mg by mouth (p.o.), daily until disease progression

2

GEM/OX/TAR

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles

Erlotinib

Intervention Type DRUG

Erlotinib 100 mg by mouth (p.o.), daily until disease progression

Oxaliplatin

Intervention Type DRUG

Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles

Interventions

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Gemcitabine

Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles

Intervention Type DRUG

Gemcitabine

Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles

Intervention Type DRUG

Erlotinib

Erlotinib 100 mg by mouth (p.o.), daily until disease progression

Intervention Type DRUG

Oxaliplatin

Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles

Intervention Type DRUG

Other Intervention Names

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Gemzar Gemzar Tarceva Eloxatin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No