Avastin and Taxotere for Esophagogastric Cancer | NCT00137813

Studies
Avastin and Taxotere for Esophagogastric Cancer

NCT00137813

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

Nov 1, 2018Actual

Enrollment

42Actual

Phase

Phase 2

Conditions

Esophageal Cancer
Gastric Cancer

Interventions

Docetaxel
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

Oct 2018

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

Aug 2004

Primary Completion Date

Sep 2006Actual

Completion Date

Sep 2009Actual

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 29, 2005

First Posted Date

Aug 30, 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

Oct 31, 2018

Last Update Posted Date

Nov 1, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter C. Enzinger, MD, Principal Investigator, Dana-Farber Cancer InstitutePrincipal Investigator

Lead Sponsor

Dana-Farber Cancer InstituteOTHER

Collaborators

Name	Class
Brigham and Women's Hospital	OTHER
Massachusetts General Hospital	OTHER
Beth Israel Deaconess Medical Center	OTHER
Genentech, Inc.

Description Module

Brief Summary

The purpose of this study is to determine what effects (good and bad) bevacizumab (Avastin) and docetaxel (Taxotere), used in combination, have on metastatic gastric and esophageal cancer.

Detailed Description

Bevacizumab will be administered intravenously in an outpatient clinic once a week, every other week. Docetaxel will also be administered intravenously in the outpatient clinic once a week for three out of four weeks. Blood tests and vital signs will be performed weekly.

After the first eight weeks of therapy a CT scan will be performed to determine and assess the progress of the disease. If therapy is continued, radiological procedures will be performed at week 16 and every 8 weeks thereafter.

Treatment will be given for a minimum of 8 weeks, as long as the patient does not experience unacceptable side effects. Chemotherapy will continue for a year and a half as long as the cancer is responding and there are no unacceptable side effects.

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

42Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Docetaxel	Drug	Given intravenously once a week for 3 out of four weeks for a minimum of 8 weeks and maximum of a year and a half		AvaTax
Bevacizumab	Drug	Given intravenously once a week for every other week for a minimum of 8 weeks and a maximum of a year and a half

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer		3 years

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed, unresectable or metastatic stage IV esophageal or gastric carcinoma
Measurable disease greater than or equal to 1cm by spiral computed tomography (CT) scan or greater than or equal to 2cm by other radiographic technique
ECOG performance status 0-2
One prior chemotherapy for metastatic disease permitted
White blood cell count greater than or equal to 3,000/mm
Absolute neutrophil count greater than or equal to 1,500/mm3
Platelet count greater than or equal to 100,000/mm3
Hemoglobin greater than or equal to 8.0g/dl
Creatinine less than 2.0mg/dL
Total bilirubin less than 1.9mg/dL

Exclusion Criteria:

Pregnant or lactating women
History or evidence of central nervous system (CNS) disease
Other active malignancies other than non-melanoma skin cancer or in-situ cervical cancer
History of severe hypersensitivity to docetaxel, bevacizumab or drugs formulated with polysorbate 80.
Current, recent or planned treatment with standard chemotherapy, radiation therapy or another experimental therapy.
History of other disease or metabolic dysfunction.
Serious, non-healing wound, ulcer, or bone fracture.

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
Peter Enzinger, MD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02115	United States
Dana-Farber Cancer Institute

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077143	Docetaxel
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided