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 — DRUG
    1 cycle: 3 weeks; 30 mg/m\^2, IV, every cycle
  • Bevacizumab (Avastin) — DRUG
    1 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)

FacilityCityStateZIPSite coordinators
Univ. of New Mexico cancer research and treatment centerAlbuquerqueNew Mexico87131-
Bellevue HospitalNew YorkNew York10016-
NYU Cancer CenterNew YorkNew York10016-
NYU medical center (Tisch Hospital)New YorkNew York10016-

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