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

Brief Title

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

Official Title

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

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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Maximum Tolerated Dose

Secondary Outcome

 Response Rate, Progression Free Survival and Overall Survival

Condition

Ovarian Cancer

Intervention

Paclitaxel

Study Arms / Comparison Groups

 Carboplatin Paclitaxel & Bevacizumab

Description:  Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

October 2010

Primary Completion Date

March 2021

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.

Gender

Female

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

David O'Malley, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01220154

Organization ID

OSU-09115

Secondary IDs

NCI-2012-00341

Responsible Party

Sponsor-Investigator

Study Sponsor

David O'Malley

Collaborators

 Genentech, Inc.

Study Sponsor

David O'Malley, MD, Principal Investigator, Ohio State University Comprehensive Cancer Center

Verification Date

October 2016