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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: David O'Malley
• Collaborator: Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Paclitaxel

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.