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Irinotecan and Bevacizumab for Recurrent Ovarian Cancer

2014-08-27 03:15:04 | BioPortfolio

Summary

In a phase II open-label study women with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma will be treated with bevacizumab 15 mg/kg and irinotecan 250mg/m2 every 3 weeks.

Description

Patients will undergo pre-treatment evaluation within 4 weeks of enrolling into the study:

- Vital signs, including blood pressure and weight, performance status (within 14 days)

- History and physical examination (within 14 days)

- CT-scan of abdomen and pelvis or CT-PET should be performed (within 28 days). The imaging study performed during pre-treatment evaluation will be repeated every six weeks from the day 1 of first cycle.

- Complete blood count, basic metabolic panel, lever function test, CA-125 (within 14 days)

- Urine protein:creatinine ratio (and 24 hour collection for protein if UPC ratio of 1 or greater was discovered) (within 28 days)

Clinical and laboratory evaluation will be performed every 3 weeks:

Vital signs, including blood pressure, performance status, blood pressure, weight and height (within 4 days)

- History and physical examination (within 4 days)

- Complete blood count, basic metabolic panel, lever function test, CA-125 (within 4 days)

Every 6 weeks:

- CT-scan of abdomen and pelvis or CT-PET. The imaging study performed during pre-treatment evaluation will be repeated every six weeks from the day 1 of first cycle (within 7 days).

- Urine dipstick or Urine protein: creatinine ratio (UPC). If, 2+ or greater proteinuria was discovered on UA, or UPC ratio of 1 or greater was previously discovered, 24-hours urine collection will be performed to measure degree of proteinuria.

Imaging studies and CA-125 measurements will be used to assess response to treatment.

POST-TREATMENT EVALUATIONS

Every 3 month for 2 years or until disease progression:

- History and physical examination

- CT-scan of abdomen and pelvis

- CA-125

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Ovarian Cancer

Intervention

Bevacizumab

Location

New York University Clinical Cancer Center
New York
New York
United States
10016

Status

Not yet recruiting

Source

New York University School of Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:04-0400

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