Status:
COMPLETED
Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
Lead Sponsor:
Ritu Salani
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Ovarian Cancer
Primary Peritoneal Cancer
Eligibility:
FEMALE
18-90 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, prim...
Detailed Description
Phase I study proposed to evaluate: * Tolerability of IV regimen carboplatin, paclitaxel and bevacizumab in the neoadjuvant setting prior to surgery. * Safety/Toxicity of IV regimen in this patient p...
Eligibility Criteria
Inclusion
- histology,cytologically diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer
- FIGO (International Federation of Gynecology and Obstetrics stage III or IV disease
- GOG (Gynecologic Oncology Group) Performance Status 0,1,2
- No prior surgery for their malignancy
- Adequate bone marrow function
- Platelet count greater than or equal to 100,000
- Renal Function: Creatinine \< 1.5 institutional upper limit normal
- Hepatic Function: Bilirubin less than 1.5 ULN (upper limit of normal)
- Hepatic Function: SGOT (serum glutamate oxaloacetate transaminase) and Alkaline Phosphate
- Neurologic Function: Neuropathy less than CTCAE (Common Toxicity Criteria for Adverse Effects)grade 1
- Coagulation Functions: INR\<1.5 and PTT ,1.2 times the upper limit of normal
- Measurable disease
Exclusion
- Previous cancer related surgery
- Received prior chemotherapy, immunotherapy, radiotherapy, hormonal therapy or biologic therapy for their ovarian, fallopian tube or primary peritoneal cancer.
- Borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer or non-epithelial ovarian are not eligible.
- Other cancers within 5 years (other than non-melanoma skin cancer)
- Acute Hepatitis or end stage liver disease
- History of prior gastrointestinal perforation
- Evidence of abdominal free air not explained by paracentesis
- Sign or symptoms of gastrointestinal obstruction
- Active bleeding or pathologic conditions that carry high risk of bleeding
- CNS (Central Nervous System) disease
- Clinically Significant cardiovascular disease
- Known hypersensitivity to Chinese Hamster ovary cell products or other recombinant human or humanized antibodies
- Clinically significant proteinuria.
- Hypertensive crises or hypertensive encephalopathy
- History of hemoptysis
- Any non-study related invasive procedure within 28 days fo first date of bevacizumab
- GOG performance status 3 or 4
- Patients who are pregnant or nursing.
- Under the age of 18
- Received prior treatment of bevacizumab or any anti-VEGF (vascular endothelial growth factor) drug
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01219777
Start Date
September 1 2010
End Date
May 1 2015
Last Update
February 8 2018
Active Locations (1)
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1
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210