Status:
COMPLETED
Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer
Lead Sponsor:
David O'Malley
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18-90 years
Phase:
PHASE1
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 previou...
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 duri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01220154
Start Date
April 28 2011
End Date
July 17 2023
Last Update
February 21 2025
Active Locations (1)
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1
OSU Gyn Oncology at Mill Run
Hilliard, Ohio, United States, 43026