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

Phase 2

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: Gemcitabine; Drug: Erlotinib; Drug: Oxaliplatin

• Registration Number: NCT00564720
• Lead Sponsor: Hellenic Oncology Research Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-11-27
• Study First Submitted QC: 2007-11-27
• Study First Posted: 2007-11-28
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gemcitabine	GEM/TAR
1	Erlotinib	GEM/TAR
2	Gemcitabine	GEM/OX/TAR
2	Erlotinib	GEM/OX/TAR
2	Oxaliplatin	GEM/OX/TAR

Primary Outcome Measures

Name	Time	Method
Overall Survival	1 year survival

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology; 🇬🇷 Athens, Greece

University General Hospital of Alexandroupolis, Department of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

Errikos Ntynan General Hospital; 🇬🇷 Athens, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

IASO General Hospital of Athens, 1st Department of Medical Oncology; 🇬🇷 Athens, Greece

Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine; 🇬🇷 Athens, Greece

Diabalkaniko General Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece

State General Hospital of Larissa; 🇬🇷 Larissa, Greece