Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitab... | NCT00564720

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

NCT00564720

Sponsor

Hellenic Oncology Research Group

Status

Terminated

Last Update Posted

Feb 15, 2013Estimated

Enrollment

140Actual

Phase

Phase 2

Conditions

Pancreatic Cancer

Interventions

Gemcitabine
Gemcitabine
Erlotinib
Oxaliplatin

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to poor accrual of the study

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Nov 27, 2007

First Submission Date that Met QC Criteria

Nov 27, 2007

First Posted Date

Nov 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2013

Last Update Posted Date

Feb 15, 2013Estimated

Name	Class
University Hospital of Crete	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	GEM/TAR	Drug: Gemcitabine Drug: Erlotinib
2	Experimental	GEM/OX/TAR	Drug: Gemcitabine Drug: Erlotinib Drug: Oxaliplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine	Drug	Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival		1 year survival

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vassilis Georgoulias, MD	University Hospital of Crete, Dep of Medical Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University General Hospital of Alexandroupolis, Department of Medical Oncology		Alexandroupoli			Greece

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine
D000069347	Erlotinib Hydrochloride
D000077150	Oxaliplatin

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided