A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

Part of paid clinical trials in Horsham, Pennsylvania.

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT00698451
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten 28-day cycles. Patients will be followed for six months following treatment to assess progression-free survival.

Key Dates

First listed
Jun 17, 2008
Start date
Aug 31, 2008
Status verified
Aug 2013
Primary completion
Oct 31, 2010
Completion
Oct 31, 2010

Study Design

Enrollment
54 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle

Primary Outcome Measure

The Primary Efficacy End Point is the Number of Patients With an Objective Response. [ Time Frame: Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
-HorshamPennsylvania19044-

Find similar trials in Horsham, PA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health

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