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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00137813 |
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Date of registration:
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29/08/2005 |
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Primary sponsor: |
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Public title:
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Avastin and Taxotere for Esophagogastric Cancer
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Scientific title:
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Phase II Study of Bevacizumab and Docetaxel (AvaTax) in Metastatic Esophagogastric Cancer |
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Date of first enrolment:
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August 2004 |
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Target sample size:
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42 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00137813 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Peter Enzinger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dana-Farber Cancer Institute |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Esophageal Cancer
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Gastric Cancer
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Intervention(s)
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Drug: Bevacizumab
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Drug: Docetaxel
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Primary Outcome(s)
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To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer
[Time Frame: 3 years]
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Secondary Outcome(s)
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To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab
[Time Frame: TBD]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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