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

NCT01220154 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-09115NCI-2012-00341
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ovarian; cancer; fallopian tube; peritoneal; intraperitoneal; bevacizumab; carboplatin; paclitaxel; chemo-naive

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  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.

  Every Cycle-28 days

Secondary Outcomes (1)

• Response Rate, Progression Free Survival and Overall Survival

  Every 3 monthes for 2 years, Every 6 months for 3 years.

Study Arms (1)

Carboplatin Paclitaxel & Bevacizumab

EXPERIMENTAL

Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab

Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab

Interventions

Paclitaxel 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.

Also known as: Abraxane, Taxol

Carboplatin Paclitaxel & Bevacizumab

Carboplatin DRUG

Intraperitoneal Day 1 cycles 1-6 AUC

Also known as: Paraplatin®

Carboplatin Paclitaxel & Bevacizumab

Bevacizumab 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

Also known as: Avastin

Carboplatin Paclitaxel & Bevacizumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• David O'Malley: lead
• Genentech, Inc.: collaborator

Study Sites (1)

OSU Gyn Oncology at Mill Run

Hilliard, Ohio, 43026, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Neoplasms

Interventions

Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• David O'Malley, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 13, 2010
• Study Start: April 28, 2011
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: February 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)