Clinical trial NCT01219777: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Keywords: bevacizumab
paclitaxel
carboplatin
ovarian
cancer
fallopian tube
primary peritoneal
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-10-13
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Tolerated Dose
timeFrame: Up to 6 months
Secondary outcomes:
measure: Toxicity and Response Rates Based on Imaging and Surgical Outcomes
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Ritu Salani, MD
role: PRINCIPAL_INVESTIGATOR
References: