Brief Title
Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
Official Title
Phase I Evaluation of Intravenous Carboplatin With Weekly Paclitaxel and Bevacizumab in Patients Undergoing Neoadjuvant Chemotherapy for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
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, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo surgery which will allow an objective measure of response to the above regimen as well as assessment of surgical outcomes.
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 population - Treatment is Carboplatin area under the concentration curve (AUC) 5, Bevacizumab 15mg/m2, and starting dose of paclitaxel of 60mg/m2 and will be escalated in intervals of 10mg/m2 to a maximum dose of 80mg/m2. - Patients will receive cycles 1-3 of carboplatin, bevacizumab, and paclitaxel and then cycle 4 will be carboplatin and paclitaxel followed by surgical intervention within 6 weeks of cycle 4. - Post surgical treatment per physician discretion
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Tolerated Dose
Secondary Outcome
Toxicity and Response Rates Based on Imaging and Surgical Outcomes
Condition
Ovarian Cancer
Intervention
carboplatin
Study Arms / Comparison Groups
Carboplatin
Description: AUC 5.0 or 6.0
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
9
Start Date
September 2010
Completion Date
May 2015
Primary Completion Date
May 2012
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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
Gender
Female
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Ritu Salani, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01219777
Organization ID
OSU-09149
Secondary IDs
NCI-2012-00512
Responsible Party
Sponsor-Investigator
Study Sponsor
Ritu Salani
Collaborators
Genentech, Inc.
Study Sponsor
Ritu Salani, MD, Principal Investigator, Ohio State University Comprehensive Cancer Center
Verification Date
May 2015