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Avastin and Taxotere for Esophagogastric Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00137813
First Posted: August 30, 2005
Last Update Posted: May 10, 2016
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.
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
  Purpose
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.

Condition Intervention Phase
Esophageal Cancer Gastric Cancer Drug: Docetaxel Drug: Bevacizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Bevacizumab and Docetaxel (AvaTax) in Metastatic Esophagogastric Cancer

Resource links provided by NLM:


Further study details as provided by Peter C. Enzinger, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab

Enrollment: 42
Study Start Date: August 2004
Estimated Study Completion Date: July 2016
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137813


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Genentech, Inc.
Sanofi
Investigators
Principal Investigator: Peter Enzinger, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Peter C. Enzinger, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00137813     History of Changes
Other Study ID Numbers: 04-179
First Submitted: August 29, 2005
First Posted: August 30, 2005
Last Update Posted: May 10, 2016
Last Verified: May 2016

Keywords provided by Peter C. Enzinger, MD, Dana-Farber Cancer Institute:
Bevacizumab
Docetaxel
AvaTax
Metastatic Esophagogastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Bevacizumab
Docetaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action