Clinical trial NCT00137813: Avastin and Taxotere for Esophagogastric Cancer
Official title: Phase II Study of Bevacizumab and Docetaxel (AvaTax) in Metastatic Esophagogastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Gastric Cancer
Keywords: Bevacizumab
Docetaxel
AvaTax
Metastatic Esophagogastric Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
name: Genentech, Inc.
name: Sanofi
First posted: 2005-08-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer
timeFrame: 3 years
Secondary outcomes:
measure: To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Peter Enzinger, MD
role: PRINCIPAL_INVESTIGATOR
References: