Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
This trial is active, not recruiting.
|Conditions||ovarian cancer, primary peritoneal cancer, fallopian tube cancer|
|Treatments||carboplatin, bevacizumab, paclitaxel|
|Start date||September 2010|
|End date||January 2014|
|Trial size||30 participants|
|Trial identifier||NCT01219777, NCI-2012-00512, OSU-09149|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 3 patients per dose level with minmum of 4 weeks observation period
time frame: 3 patients per dose level, then minmum of 4 week observation period
Female participants from 18 years up to 90 years old.
Inclusion Criteria: - histology,cytologically diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer - FIGO stage III or IV disease - GOG 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 - Hepatic Function: SGOT and Alkaline Phosphate - Neurologic Function: Neuropathy less than CTCAE 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 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 28days 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 drug
|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|
|Principal investigator||Ritu Salani, MD|
|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|
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