Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer

NCT ID: NCT01220154

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-28
• Study Completion Date: 2023-07-17

Brief Summary

Phase I study to evaluate intraperitoneal carboplatin along with weekly intravenous paclitaxel and bevacizumab in order to establish a tolerable dose and define the toxicity of this regimen in previously untreated patients with advanced ovarian carcinoma.

Detailed Description

Phase I study with the primary objective to determine the maximum tolerated dose of intraperitoneal carboplatin and intravenous weekly paclitaxel given in combination with intravenous bevacizumab during the second two cycles of treatment in patients with chemo-naive epithelial ovarian, primary peritoneal or fallopian tube cancer. The maximum tolerated dose is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose limiting toxicity during the second two cycles of treatment. Secondary objectives are to determine response rates and to estimate progression free survival and overall survival of this class of patients.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; No Prior Chemotherapy

Study Design

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

Study Groups

Carboplatin Paclitaxel & Bevacizumab

Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Cycle 1 Day 1, 8, 15 IV 60-80mg mg/m2 as a 1 hour infusion. For cycle 2-6 Day 1,8,15 IV 60-80 mg/m2 as 1 hour infusion. Repeat every 3 weeks times 5 cycles.

Carboplatin

Intervention Type: DRUG

Intraperitoneal Day 1 cycles 1-6 AUC

Bevacizumab

Intervention Type: DRUG

Bevacizumab 15 mg/kg intravenous infusion Day 1 cycles 2-6 Optional cycles 7-22 15 mg/kg intravenous infusion Day 1 every 21 days

Interventions

Paclitaxel

Cycle 1 Day 1, 8, 15 IV 60-80mg mg/m2 as a 1 hour infusion. For cycle 2-6 Day 1,8,15 IV 60-80 mg/m2 as 1 hour infusion. Repeat every 3 weeks times 5 cycles.

Intervention Type: DRUG

Carboplatin

Intraperitoneal Day 1 cycles 1-6 AUC

Intervention Type: DRUG

Bevacizumab

Bevacizumab 15 mg/kg intravenous infusion Day 1 cycles 2-6 Optional cycles 7-22 15 mg/kg intravenous infusion Day 1 every 21 days

Intervention Type: DRUG

Other Intervention Names

Abraxane; Taxol; Paraplatin®; Avastin

Eligibility Criteria

Inclusion Criteria

• Histology diagnoses epithelial ovarian, primary peritoneal, or fallopian tube(Stage II, III or IV)either optimal or suboptimal after initial surgery.

• All patients must have had appropriate surgery for ovarian, peritoneal, or fallopian tube carcinoma with tissue available for histologic evaluation
• Histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant brenner tumor, adenocarcinoma NOS.
• GOG(Gynecologic Oncology Group)performance status of 0,1,2
• Entered within 12 weeks of most recent surgery performed for diagnosis.
• Patients must have adequate bone marrow function, renal function,hepatic function, neurologic function, blood coagulation parameters within normal limits
• Sign approved consent form.

Exclusion Criteria

• Patients who have received prior treatment other than initial surgery
• Patients who have received prior radiotherapy to any portion of their abdominal cavity or pelvis
• Patients with acute hepatitis or active infection
• Patients with active bleeding
• Patients with unstable angina
• Patients with history of invasive malignancies with the exception of nonmelanoma skin cancer and localized breast cancer.
• Patients who have received any target therapy or hormonal therapy for management of their ovarian cancer.
• Patients with synchronous primary endometrial cancer.
• Patients with epithelial tumors of low malignant potential
• Serious non healing wound, ulcer or bone fracture.
• Patients with history or evidence of CNS(central nervous system disease)
• Patients under 18 years old.
• Patients who have received prior therapy with anti-VEGF(vascular endothelial growth factor)

drug, bevacizumab

• Patients who have a history of allergic reaction to polysorbate 80.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

David O'Malley

OTHER

Sponsor Role: lead

Responsible Party

David O'Malley

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David O'Malley, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

OSU Gyn Oncology at Mill Run

Hilliard, Ohio, United States

Countries

United States

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2012-00341

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-09115

Identifier Type: -

Identifier Source: org_study_id