Avastin and Taxotere for Esophagogastric Cancer
Status: | Completed |
---|---|
Conditions: | Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/3/2018 |
Start Date: | August 2004 |
End Date: | September 2009 |
Phase II Study of Bevacizumab and Docetaxel (AvaTax) in Metastatic 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.
and docetaxel (Taxotere), used in combination, have on metastatic gastric and esophageal
cancer.
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.
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.
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.
We found this trial at
3
sites
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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