Pharmacokinetic Study of Avastin and Doxil in Ovarian Cancer
Part of paid clinical trials in Albuquerque, New Mexico.
- Sponsor
- NYU Langone Health
- Study ID
- NCT00846612
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Doxil — DRUG1 cycle: 3 weeks; 30 mg/m\^2, IV, every cycle
- Bevacizumab (Avastin) — DRUG1 cycle: every 3 weeks; 15 mg/kg, IV, beginning on cycle 2 and every cycle 20-24 hours following Doxil administration
Study Details
This study is to study pharmacokinetics of Doxil using Doxil and Avastin on ovarian cancer patients who are resistant to or have relapsed from platinum-based therapy.
Key Dates
- First listed
- Feb 19, 2009
- Start date
- Jan 31, 2008
- Status verified
- Sep 2019
- Primary completion
- Sep 30, 2010
- Completion
- Jun 30, 2012
Study Design
- Enrollment
- 15 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Avastin-Doxil
Primary Outcome Measure
change in peak plasma concentration of Doxil without and with Avastin [ Time Frame: 1 hour, 1, 4, 7, 10, 14, and 21 days post-dose in cycle 1 and cycle 2 ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Univ. of New Mexico cancer research and treatment center | Albuquerque | New Mexico | 87131 | - |
| Bellevue Hospital | New York | New York | 10016 | - |
| NYU Cancer Center | New York | New York | 10016 | - |
| NYU medical center (Tisch Hospital) | New York | New York | 10016 | - |
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