Avastin and Taxotere for Esophagogastric Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00137813

Enrollment

Registered

2005-08-30

Start date

2004-08-31

Completion date

2009-09-30

Last updated

2018-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Gastric Cancer

Keywords

Bevacizumab, Docetaxel, AvaTax, 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.

Interventions

DRUGDocetaxel

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

DRUGBevacizumab

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 design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer	3 years

Secondary

Measure	Time frame
To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026