Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
University of New Mexico
Study ID
NCT00277069
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Breast
  • Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Carboplatin given at 300mg/m2 IV over 30 minutes day 1, q 21 days
  • Capecitabine — DEVICE
    Capecitabine is administered at 1500mg/m2 PO qd in 2 divided doses day 1-14 q 21 days
  • Vinorelbine — DRUG
    Vinorelbine: 25mg/m2 IV over 10 minutes day 1, 8 q 21 days

Study Details

1\. Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.

Key Dates

Start date
May 31, 2000
Status verified
Oct 2008
Primary completion
Mar 31, 2005
Completion
Mar 31, 2006

Study Design

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

Primary Outcome Measure

Measurable disease: Bidimensionally measurable lesions with clearly defined margins by 1) palpation with both diameters greater than 1 cm, 2) CT, MRI with both diameters greater than the distance between cuts of the imaging study. [ Time Frame: disease progression or unacceptable toxicities ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of New MexicoAlbuquerqueNew Mexico87131-

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University of New Mexico· Albuquerque, NM

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