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

David O'Malley

Status and phase

Completed

Phase 1

Conditions

Primary Peritoneal Cancer

No Prior Chemotherapy

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Drug: Bevacizumab

Drug: Paclitaxel

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01220154

OSU-09115

NCI-2012-00341 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

Accepts 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)