Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT00194727
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
  • Capecitabine — DRUG
    825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.

Study Details

The primary purpose of the study is to examine the safety and effectiveness of combination therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV breast cancer subjects. The study is designed to assess the safety and effectiveness of this combination therapy. Safety will be assessed by analyzing the types of toxicity, the severity of toxicity and the need for dose modification or delay due to toxicity. Effectiveness will be assessed by analyzing response rates, time to treatment failure, time to progression and overall survival. Our hypothesis is that the regimen will be more effective than standard historic regimens for this type and stage of cancer.

Key Dates

Start date
May 31, 2002
Status verified
Sep 2012
Primary completion
Mar 31, 2011
Completion
Mar 31, 2011

Study Design

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

Arms

  • Experimental: 1
    Vinorelbine (20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle) and capecitabine (825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle). Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.

Primary Outcome Measure

Best response as determined at the time that the subject completes protocol treatment [ Time Frame: <= 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington; Seattle Cancer Care AllianceSeattleWashington98109-1023-

Find similar trials in Seattle, WA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Washington; Seattle Cancer Care Alliance· Seattle, WA

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