Gemcitabine, Oxaliplatin in Combination With Bevacizumab... | NCT00142467

Studies
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma

NCT00142467

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Mar 18, 2014Estimated

Enrollment

33Actual

Phase

Phase 2

Conditions

Hepatocellular Carcinoma

Interventions

Gemcitabine
Oxaliplatin
Bevacizumab

Countries

United States

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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Aug 2006Actual

Completion Date

Jun 2011Actual

First Submitted Date

Aug 31, 2005

First Submission Date that Met QC Criteria

Aug 31, 2005

First Posted Date

Sep 2, 2005Estimated

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

Mar 15, 2014

Last Update Posted Date

Mar 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrew X. Zhu, MD, Principal Investigator, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Dana-Farber Cancer Institute	OTHER
Beth Israel Deaconess Medical Center	OTHER
Brigham and Women's Hospital	OTHER
Genentech, Inc.

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with hepatocellular carcinoma.

Detailed Description

Treatment is given in cycles, each cycle (except for cycle 1) is 4 weeks long. Cycle 1 is only 2 weeks long.
During cycle one only, bevacizumab will be given intravenously on day one. Two weeks after receiving bevacizumab, the patient will return to the clinic for treatment with all 3 study drugs.
During cycle 2 and every cycle thereafter patients will receive; bevacizumab intravenously on day one and day 15; gemcitabine intravenously on day 2 and day 16; oxaliplatin intravenously on day 2 and day 16.
The following evaluations will be conducted on day 1 and day 15 of each cycle (once every 2 weeks): physical examination, vital signs, medical history, blood tests and urine tests.
Tumor measurements done by CT and/or MRI will be repeated at the end of cycle 3 and every 2 cycles thereafter.
Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) of the liver and Perfusions CT scans will also be done on days 10-12 following bevacizumab treatment during cycle 1, and the Perfusion CT will be repeated at the end of cycle 3.
Once study treatment is stopped the following evaluations will be performed: physical exam, vital signs, blood work, urine tests, CT scan of chest, abdomen and pelvis, and tumor measurements by CT or MRI scans.
Follow-up will consist of physical examinations and blood tests every 6 months.
Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.

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

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bevacizumab, Gemcitabine, Oxaliplatin	Experimental	For cycle 1 (14 days), bevacizumab 10 mg/kg was administered alone on day 1. For cycle 2 and beyond (28 days/cycle), bevacizumab 10 mg/kg was administered on days 1 and 15, gemcitabine 1,000 mg/m2 was administered as a dose rate infusion at 10 mg/m2/min followed by oxaliplatin at 85 mg/m2 on days 2 and 16. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death.	Drug: Gemcitabine Drug: Oxaliplatin Drug: Bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine	Drug		Bevacizumab, Gemcitabine, Oxaliplatin	Gemzar
Oxaliplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	2 years

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events		2 years
Objective response rate		2 years
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unresectable or metastatic hepatocellular carcinoma
Measurable tumors
Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7x ULN
Adequate bone marrow function: ANC > 1,000/mm3; platelets > 75,000/mm3
INR < 1.5 for those who are not on anticoagulation
Up to two prior chemotherapy regimens for hepatocellular carcinoma
18 years of age or older
ECOG performance status of 0-1
Life expectancy of > 12 weeks

Exclusion Criteria:

Clinically apparent central nervous system metastases or carcinomatous meningitis
Uncontrolled serious medical or psychiatric illness
Pregnant or lactating women
Current or recent (within 4 weeks of first study infusion) participation in experimental study drug
Uncontrolled hypertension
Significant proteinuria
Serious, non-healing wound, ulcer, or bone fracture
Evidence of bleeding diathesis or coagulopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Zhu, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
Beth Israel Deaconess Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine
D000077150	Oxaliplatin
D000068258	Bevacizumab

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided