Sorafenib and Vinorelbine in Treating Women With Stage IV Breast Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT00828074
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • sorafenib tosylate — DRUG
    Dose level 1 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle. Dose level 2 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle. Dose level 3 = 200 mg by mouth in the am and 400 mg by mouth in the pm on days 1-28 of a 28 day cycle. Dose level 4 = 400 mg by mouth two times a day on days 1-28 of a 28 day cycle.
  • vinorelbine ditartrate — DRUG
    Dose level 1 = 20 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 2 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 3 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 4 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle.

Study Details

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with vinorelbine may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib when given together with vinorelbine and to see how well they work in treating women with stage IV breast cancer.

Key Dates

Start date
Nov 30, 2008
Status verified
Jan 2017
Primary completion
Apr 30, 2014
Completion
Apr 30, 2014

Study Design

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

Arms

  • Experimental: Treatment (vinorelbine tartrate and sorafenib tosylate)
    Patients receive sorafenib tosylate PO twice daily on days 1-28 and vinorelbine ditartrate IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With at Least One Dose Limiting Toxicity in Phase I [ Time Frame: 4 weeks from start of treatment, up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-3000-
South Pasadena Cancer CenterPasadenaCalifornia91030-

Find similar trials in Duarte, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
City of Hope Medical Center· Duarte, CASouth Pasadena Cancer Center· Pasadena, CA

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