Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian

NCT ID: NCT01219777

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-05-31

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

Conditions

Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carboplatin

AUC 5.0 or 6.0

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.

Bevacizumab

15 mg/kg

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.

Paclitaxel

60-80 mg/m2

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

60-80 mg/m2 administered on Day 1, 8 \& 15 during cycle 1-3. Treatment cycle consists of 21 days duration.

Interventions

carboplatin

Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.

Intervention Type: DRUG

Bevacizumab

Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.

Intervention Type: DRUG

Paclitaxel

60-80 mg/m2 administered on Day 1, 8 \& 15 during cycle 1-3. Treatment cycle consists of 21 days duration.

Intervention Type: DRUG

Other Intervention Names

Paraplatin®; CBDCA; Avastin; Taxol; Abraxane

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Ritu Salani

OTHER

Sponsor Role: lead

Responsible Party

Ritu Salani

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ritu Salani, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

The Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Related Links

http://cancer.osu.edu

Jamesline

Other Identifiers

NCI-2012-00512

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-09149

Identifier Type: -

Identifier Source: org_study_id