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

Ovarian Cancer Clinical Trial

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

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. 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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• No Prior Chemotherapy
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Cancer

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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