Avastin and Taxotere for Esophagogastric Cancer

Gastric Cancer Clinical Trial

Official title:

Phase II Study of Bevacizumab and Docetaxel (AvaTax) in Metastatic Esophagogastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137813
• Other study ID #: 04-179
• Status: Completed
• Phase: Phase 2
• Start date: August 2004
• Est. completion date: September 2009

Study information

• Verified date: October 2018
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2009
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

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
• 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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Massachusetts General Hospital, Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer		3 years
Secondary	To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab