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Phase I Study of Intraperitoneal Carboplatin With Intravenous Paclitaxel and Bevacizumab in Patients With Previously Untreated Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma


Phase 1
18 Years
90 Years
Open (Enrolling)
Female
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, No Prior Chemotherapy

Thank you

Trial Information

Phase I Study of Intraperitoneal Carboplatin With Intravenous Paclitaxel and Bevacizumab in Patients With Previously Untreated Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome 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.

Outcome Time Frame:

Every Cycle-28 days

Safety Issue:

Yes

Principal Investigator

David O'Malley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

OSU-09115

NCT ID:

NCT01220154

Start Date:

October 2010

Completion Date:

October 2020

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • No Prior Chemotherapy
  • ovarian
  • cancer
  • fallopian tube
  • peritoneal
  • intraperitoneal
  • bevacizumab
  • carboplatin
  • paclitaxel
  • chemo-naive
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

OSU Gyn Oncology at Mill RunHilliard, Ohio  43026