Clinical trial NCT01220154: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
No Prior Chemotherapy
Keywords: ovarian
cancer
fallopian tube
peritoneal
intraperitoneal
bevacizumab
carboplatin
paclitaxel
chemo-naive
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-10-13
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: Every Cycle-28 days
Secondary outcomes:
measure: Response Rate, Progression Free Survival and Overall Survival
timeFrame: Every 3 monthes for 2 years, Every 6 months for 3 years.
Other outcomes:
Locations:
city: Hilliard
country: United States
facility: OSU Gyn Oncology at Mill Run
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: David O'Malley, MD
role: PRINCIPAL_INVESTIGATOR
References: