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
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: November 30, 2012
Last verified: November 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

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 [ Time Frame: TBD ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: August 2004
Estimated Study Completion Date: December 2012
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137813

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
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
Sanofi
Investigators
Principal Investigator: Peter Enzinger, MD Dana-Farber Cancer Institute
  More Information

No publications provided

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
Study First Received: August 29, 2005
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Bevacizumab
Docetaxel
AvaTax
Metastatic Esophagogastric Cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014