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

Sponsor

David O'Malley (Other)

Overall Status

Unknown status

CT.gov ID

NCT01220154

Collaborator

Genentech, Inc. (Industry)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer No Prior Chemotherapy	Drug: Paclitaxel Drug: Carboplatin Drug: Bevacizumab	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carboplatin Paclitaxel & Bevacizumab Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab	Drug: Paclitaxel Cycle 1 Day 1, 8, 15 IV 60-80mg mg/m2 as a 1 hour infusion. For cycle 2-6 Day 1,8,15 IV 60-80 mg/m2 as 1 hour infusion. Repeat every 3 weeks times 5 cycles. Other Names: Abraxane Taxol Drug: Carboplatin Intraperitoneal Day 1 cycles 1-6 AUC Other Names: Paraplatin® Drug: Bevacizumab Bevacizumab 15 mg/kg intravenous infusion Day 1 cycles 2-6 Optional cycles 7-22 15 mg/kg intravenous infusion Day 1 every 21 days Other Names: Avastin

Arm

Intervention/Treatment

Experimental: Carboplatin Paclitaxel & Bevacizumab

Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab

Drug: Paclitaxel

Cycle 1 Day 1, 8, 15 IV 60-80mg mg/m2 as a 1 hour infusion. For cycle 2-6 Day 1,8,15 IV 60-80 mg/m2 as 1 hour infusion. Repeat every 3 weeks times 5 cycles.

Other Names:

Abraxane

Taxol

Drug: Carboplatin

Intraperitoneal Day 1 cycles 1-6 AUC

Other Names:

Paraplatin®

Drug: Bevacizumab

Bevacizumab 15 mg/kg intravenous infusion Day 1 cycles 2-6 Optional cycles 7-22 15 mg/kg intravenous infusion Day 1 every 21 days

Other Names:

Avastin

Outcome Measures

Primary Outcome Measures

Maximum Tolerated Dose [Every Cycle-28 days]
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.

Secondary Outcome Measures

Response Rate, Progression Free Survival and Overall Survival [Every 3 monthes for 2 years, Every 6 months for 3 years.]
Response Rate in patients with measurable disease using the RECIST(Response Evaluation Criteria in Solid Tumors)criteria. Progression free survival is also uses the RECIST criteria or GCIG criteria. Overall survival will be followed for 5 years.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)