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

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
Bevacizumab
Sponsored by
David O'Malley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian, cancer, fallopian tube, peritoneal, intraperitoneal, bevacizumab, carboplatin, paclitaxel, chemo-naive

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • OSU Gyn Oncology at Mill Run

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carboplatin Paclitaxel & Bevacizumab

Arm Description

Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Response Rate, Progression Free Survival and Overall Survival
Response Rate in patients with measurable disease using the RECIST(Response Evaluation Criteria in Solid Tumors)criteria. Progression free survival is also uses the RECIST criteria or GCIG criteria. Overall survival will be followed for 5 years.

Full Information

First Posted
October 12, 2010
Last Updated
October 12, 2016
Sponsor
David O'Malley
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01220154
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David O'Malley
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, No Prior Chemotherapy
Keywords
ovarian, cancer, fallopian tube, peritoneal, intraperitoneal, bevacizumab, carboplatin, paclitaxel, chemo-naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carboplatin Paclitaxel & Bevacizumab
Arm Type
Experimental
Arm Description
Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Abraxane, Taxol
Intervention Description
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
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin®
Intervention Description
Intraperitoneal Day 1 cycles 1-6 AUC
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Description
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.
Time Frame
Every Cycle-28 days
Secondary Outcome Measure Information:
Title
Response Rate, Progression Free Survival and Overall Survival
Description
Response Rate in patients with measurable disease using the RECIST(Response Evaluation Criteria in Solid Tumors)criteria. Progression free survival is also uses the RECIST criteria or GCIG criteria. Overall survival will be followed for 5 years.
Time Frame
Every 3 monthes for 2 years, Every 6 months for 3 years.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David O'Malley, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
OSU Gyn Oncology at Mill Run
City
Hilliard
State/Province
Ohio
ZIP/Postal Code
43026
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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