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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer, Gastric Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Peter Enzinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

04-179

NCT ID:

NCT00137813

Start Date:

August 2004

Completion Date:

December 2012

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • Bevacizumab
  • Docetaxel
  • AvaTax
  • Metastatic Esophagogastric Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617