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Avastin and Taxotere for Esophagogastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137813
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : November 1, 2018
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Genentech, Inc.
Sanofi
Information provided by (Responsible Party):
Peter C. Enzinger, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE August 29, 2005
First Posted Date  ICMJE August 30, 2005
Last Update Posted Date November 1, 2018
Study Start Date  ICMJE August 2004
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Avastin and Taxotere for Esophagogastric Cancer
Official Title  ICMJE Phase II Study of Bevacizumab and Docetaxel (AvaTax) in Metastatic Esophagogastric Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Esophageal Cancer
  • Gastric Cancer
Intervention  ICMJE
  • Drug: Docetaxel
    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
    Other Name: AvaTax
  • Drug: Bevacizumab
    Given intravenously once a week for every other week for a minimum of 8 weeks and a maximum of a year and a half
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2007)
42
Original Enrollment  ICMJE
 (submitted: August 29, 2005)
39
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137813
Other Study ID Numbers  ICMJE 04-179
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter C. Enzinger, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Genentech, Inc.
  • Sanofi
Investigators  ICMJE
Principal Investigator: Peter Enzinger, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP