Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
New Mexico Cancer Research Alliance
Study ID
NCT01202890
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Lenalidomide, Liposomal Doxorubicin, Bevacizumab — DRUG
    At the expansion phase: Revlimid 20 mg (days 1-21), Doxil 30 mg/m2 on Day 1 and Avastin 15 mg/kg on Day 1, every 3 weeks. If this regimen is not cumulatively tolerable, Avastin will be administered every other course. Patients will be received up to 6 cycles or disease progression, followed by Revlimid maintenance at 25 mg PO q Day for 3 weeks every 4 weeks in patients with stable disease.
  • Revlimid, Doxil, Avastin — DRUG
    At the expansion phase: Revlimid 20 mg (days 1-21), Doxil 30 mg/m2 on Day 1 and Avastin 15 mg/kg on Day 1, every 3 weeks. If this regimen is not cumulatively tolerable, Avastin will be administered every other course. Patients will be received up to 6 cycles or disease progression, followed by Revlimid maintenance at 25 mg PO q Day for 3 weeks every 4 weeks in patients with stable disease.

Study Details

This study will test the feasibility of combining 3 drugs, Revlimid with Doxil and Bevacizumab,and gather preliminary data on the potential activity of the combination in patients with platinum resistant/refractory ovarian cancer.

Key Dates

First listed
Sep 16, 2010
Start date
Sep 30, 2010
Status verified
Jan 2014
Primary completion
May 31, 2011
Completion
May 31, 2012

Study Design

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

Arms

  • Experimental: Arm 1
    At the expansion phase: Revlimid 20 mg (days 1-21), Doxil 30 mg/m2 on Day 1 and Avastin 15 mg/kg on Day 1, every 3 weeks. If this regimen is not cumulatively tolerable, Avastin will be administered every other course. Patients will be received up to 6 cycles or disease progression, followed by Revlimid maintenance at 25 mg PO q Day for 3 weeks every 4 weeks in patients with stable disease.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of the 3 drug combination and recommend a dose for phase II studies. [ Time Frame: 6-8 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87106-

Find similar trials in Albuquerque, NM

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of New Mexico Cancer Center· Albuquerque, NM

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