Abraxane/Bevacizumab

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT01821859
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Abraxane — DRUG
    Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.
  • Bevacizumab — DRUG
    Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.

Study Details

The protocol will study the effect of the combination of two drugs-Abraxane and Bevacizumab-on a subject's ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. This study drug combination will be given to subjects who have already been treated for their cancer with other chemotherapy, and now their cancer has become worse or has come back again. Neither one of these study drugs has been approved by the FDA for treatment in these three types of cancer.

Key Dates

First listed
Apr 1, 2013
Start date
Jan 31, 2010
Status verified
Jul 2013
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Abraxane/Bevacizumab
    Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion. Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.

Primary Outcome Measure

Number of Participants With Progression Free Survival Rate at 6 Months as Defined as Complete Response, Partial Response, or Stable Disease. [ Time Frame: 6 months after start of dosing ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239-

Find similar trials in Portland, OR

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
OHSU Knight Cancer Institute· Portland, OR

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