Overview

This trial is active, not recruiting.

Conditions ovarian cancer, primary peritoneal cancer, fallopian tube cancer
Treatments carboplatin, bevacizumab, paclitaxel
Phase phase 1
Target VEGF
Sponsor Ritu Salani
Collaborator Genentech
Start date September 2010
End date January 2014
Trial size 30 participants
Trial identifier NCT01219777, NCI-2012-00512, OSU-09149

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
AUC 5.0 or 6.0
carboplatin Paraplatin®
Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
(Experimental)
15 mg/kg
bevacizumab Avastin
Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
(Experimental)
60-80 mg/m2
paclitaxel Taxol
60-80 mg/m2 administered on Day 1, 8 & 15 during cycle 1-3. Treatment cycle consists of 21 days duration.

Primary Outcomes

Measure
Tolerated Dose
time frame: 3 patients per dose level with minmum of 4 weeks observation period

Secondary Outcomes

Measure
Safety/Toxicity
time frame: 3 patients per dose level, then minmum of 4 week observation period

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.