Trials / Completed
CompletedNCT01220154
Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer
Phase I Study of Intraperitoneal Carboplatin With Intravenous Paclitaxel and Bevacizumab in Patients With Previously Untreated Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- David O'Malley · Academic / Other
- Sex
- Female
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | Carboplatin | Intraperitoneal Day 1 cycles 1-6 AUC |
| 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 |
Timeline
- Start date
- 2011-04-28
- Primary completion
- 2023-07-17
- Completion
- 2023-07-17
- First posted
- 2010-10-13
- Last updated
- 2025-02-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01220154. Inclusion in this directory is not an endorsement.