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

Primary Purpose

Pancreatic Cancer

Status

Terminated

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Gemcitabine

Erlotinib

Oxaliplatin

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University General Hospital of Alexandroupolis, Department of Medical Oncology
Air Forces Military Hospital of Athens
Errikos Ntynan General Hospital
IASO General Hospital of Athens, 1st Department of Medical Oncology
Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine
Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
State General Hospital of Larissa
Diabalkaniko General Hospital of Thessaloniki

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

GEM/TAR

GEM/OX/TAR

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progression free interval

Response rate

Toxicity profile

Symptoms improvement

Full Information

NCT ID

NCT00564720

First Posted

November 27, 2007

Last Updated

February 14, 2013

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

1. Study Identification

Unique Protocol Identification Number

NCT00564720

Brief Title

Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in 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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Terminated

Why Stopped

Due to poor accrual of the study

Study Start Date

December 2006 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

GEM/TAR

Arm Title

Arm Type

Experimental

Arm Description

GEM/OX/TAR

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Other Intervention Name(s)

Tarceva

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

Eloxatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

1 year survival

Secondary Outcome Measure Information:

Title

Progression free interval

Time Frame

1 year

Title

Response rate

Time Frame

Objective responses confirmed by CT or MRI on 3rd and 6th cycle

Title

Toxicity profile

Time Frame

Toxicity assessment on each chemotherapy cycle

Title

Symptoms improvement

Time Frame

Assessment every two cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vassilis Georgoulias, MD

Organizational Affiliation

University Hospital of Crete, Dep of Medical Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University General Hospital of Alexandroupolis, Department of Medical Oncology

City

Alexandroupolis

Country

Greece

Facility Name

Air Forces Military Hospital of Athens

City

Athens

Country

Greece

Facility Name

Errikos Ntynan General Hospital

City

Athens

Country

Greece

Facility Name

IASO General Hospital of Athens, 1st Department of Medical Oncology

City

Athens

Country

Greece

Facility Name

Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine

City

Athens

Country

Greece

Facility Name

Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology

City

Athens

Country

Greece

Facility Name

State General Hospital of Larissa

City

Larissa

Country

Greece

Facility Name

Diabalkaniko General Hospital of Thessaloniki

City

Thessaloniki

Country

Greece

12. IPD Sharing Statement

Learn more about this trial

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

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