Study of Combined RHUMAB VEGF and Capecitabine-based Chem... | NCT00047710

Studies
Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer

NCT00047710

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Aug 1, 2012Estimated

Enrollment

48Actual

Phase

Phase 1

Conditions

Pancreatic Cancer

Interventions

Bevacizumab
Capecitabine
Radiotherapy

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

Jul 2012

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

Sep 2002

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Oct 14, 2002

First Submission Date that Met QC Criteria

Oct 15, 2002

First Posted Date

Oct 16, 2002Estimated

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

Jul 31, 2012

Last Update Posted Date

Aug 1, 2012Estimated

Name	Class
Genentech, Inc.	INDUSTRY

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

The goal of this clinical research study is to find the highest safe dose of the drug Bevacizumab that can be given in combination with chemoradiation for the treatment of pancreatic cancer. The effect that this combination treatment has on the tumor will also be studied.

Detailed Description

This study administers 50.4 Gy of radiation for unresectable pancreatic cancer with concurrent capecitabine and an experimental drug, Bevacizumab. The drug is an antiangiogenic agent (kills tumor blood vessels) and has been shown in preclinical models to enhance the antitumor effect of radiation and chemotherapy.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bevacizumab	Experimental	Radiation, Bevacizumab, and Capecitabine	Drug: Bevacizumab Drug: Capecitabine Radiation: Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug	Beginning 2 weeks prior to radiotherapy, dose of 5 mg/kg by vein then of 2.5 mg/kg during radiotherapy for four weeks every 2 weeks (three doses).	Bevacizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of combination Radiation, Bevacizumab, and Capecitabine.		6 weeks after the completion of therapy

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the local tumor response and median survival in patients treated with the above regimen.		6 weeks after the completion of therapy.
To evaluate VEGF serum levels before and after anti-VEGF therapy.		6 weeks after the completion of therapy.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cytology or histologic proof of adenocarcinoma of the pancreatic head, body or tail prior to treatment.
Patients with nonmetastatic, unresectable, disease are eligible.
Patients with regional nodal disease are eligible.
Karnofsky performance status >/=70.
No upper age restriction.
Absolute granulocyte count >1,500 cells/mm3 and platelet count at least 100,000 cells/mm3.
Serum bilirubin less than 5mg/dl prior to the start of therapy with adequate biliary decompression.
Adequate bilateral renal function.
Serum creatinine <1.5 mg/dl.
Adequate liver function; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST)\

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher H. Crane, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas MDAnderson Cancer Center		Houston	Texas	77030	United States

Label	URL
UT MD Anderson Cancer Center website	View source

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
D000068258	Bevacizumab
D000069287	Capecitabine
D011878	Radiotherapy

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided