Avastin and Taxotere for Esophagogastric Cancer

• ClinicalTrials.gov Identifier: NCT00137813
• Recruitment Status: Completed
• First Posted: August 30, 2005
• Last Update Posted: November 1, 2018
• Sponsor: Dana-Farber Cancer Institute
• 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: August 29, 2005
• First Posted Date: August 30, 2005
• Last Update Posted Date: November 1, 2018
• Study Start Date: August 2004
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (submitted: August 29, 2005): To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer.
• Current Secondary Outcome Measures (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 (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: Avastin and Taxotere for Esophagogastric Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Esophageal Cancer
• Gastric Cancer

Intervention

• 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: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2007): 42
• Original Enrollment (submitted: August 29, 2005): 39
• Actual Study Completion Date: September 2009
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00137813
• Other Study ID Numbers: 04-179
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Peter C. Enzinger, MD, Dana-Farber Cancer Institute
• Study Sponsor: Dana-Farber Cancer Institute

Collaborators

• 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

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: October 2018