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Avastin and Taxotere for Esophagogastric Cancer

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT00137813
First received: August 29, 2005
Last updated: May 9, 2016
Last verified: May 2016
History of Changes

August 29, 2005
May 9, 2016
August 2004
September 2006   (final data collection date for primary outcome measure)
To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer.
Complete list of historical versions of study NCT00137813 on ClinicalTrials.gov Archive Site
To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab [ Time Frame: TBD ] [ Designated as safety issue: No ]
To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab.
Not Provided
Not Provided
 
Avastin and Taxotere for Esophagogastric Cancer
Phase II Study of Bevacizumab and Docetaxel (AvaTax) in Metastatic Esophagogastric Cancer
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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
July 2016
September 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00137813
04-179
Not Provided
Not Provided
Not Provided
Peter C. Enzinger, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Genentech, Inc.
  • Sanofi
Principal Investigator: Peter Enzinger, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
May 2016

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