Avastin and Taxotere for Esophagogastric Cancer

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00137813

Collaborator

Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other), Beth Israel Deaconess Medical Center (Other), Genentech, Inc. (Industry), Sanofi (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Gastric Cancer	Drug: Docetaxel Drug: Bevacizumab	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

42 participants

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

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Sep 1, 2009

Outcome Measures

Primary Outcome Measures

To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer [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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02115