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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01220154
Other study ID # OSU-09115
Secondary ID NCI-2012-00341
Status Active, not recruiting
Phase Phase 1
First received October 12, 2010
Last updated October 12, 2016
Start date October 2010

Study information

Verified date October 2016
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 9
Est. completion date
Est. primary completion date March 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 90 Years
Eligibility 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.

Study Design

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


Intervention

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.
Carboplatin
Intraperitoneal Day 1 cycles 1-6 AUC
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

Locations

Country Name City State
United States OSU Gyn Oncology at Mill Run Hilliard Ohio

Sponsors (2)

Lead Sponsor Collaborator
David O'Malley Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose 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. Every Cycle-28 days Yes
Secondary Response Rate, Progression Free Survival and Overall Survival 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.
Every 3 monthes for 2 years, Every 6 months for 3 years. No
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