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Completed

NCT Number: NCT00137813

Avastin and Taxotere for Esophagogastric Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

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 names: AvaTax

Bevacizumab

Drug

Given intravenously once a week for every other week for a minimum of 8 weeks and a maximum of a year and a half

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Genentech, Inc.
  • Massachusetts General Hospital
  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2009
First posted
Aug 30, 2005
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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