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Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

Phase I Study of Intraperitoneal Carboplatin With Intravenous Paclitaxel and Bevacizumab in Patients With Previously Untreated Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma

NCT01220154•David O'Malley

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 90 years

Sex

FEMALE

Healthy Volunteers

Yes

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.
+5 more criteria

Locations (1)

OSU Gyn Oncology at Mill Run

Hilliard, Ohio, United States

Key Dates

Start Date

April 28, 2011

Primary Completion Date

July 17, 2023

Completion Date

July 17, 2023

Last Updated

February 21, 2025

Enrollment

ACTUAL participants

Conditions

Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerNo Prior Chemotherapy

Interventions

Paclitaxel

DRUG

Carboplatin

DRUG

Bevacizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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