Breast Neoplasms
Conditions
Brief summary
This study is to evaluate the safety of SU011248 in combination with paclitaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.
Interventions
DRUGSU011248
SU011248 provided as capsules. The starting dose is 25 mg orally, daily in a continuous regimen beginning on day 2. Dose rest for 1 week is allowed. Dose escalation to 37.5 mg po OD is allowed within the constraints of acceptable toxicity parameters. Dosing will continue for 1 year or until disease progression or unacceptable toxicity, whichever comes first.
DRUGPaclitaxel
Paclitaxel is provided as an intravenous infusion for 1 hour weekly for 3 weeks followed by a 1-week rest. The starting dose is 90 mg/m2. The weekly dose may be decreased to 65 mg/m2 in subsequent cycles based on tolerability. Dosing will continue for 1 year or until maximum benefit, disease progression or unacceptable toxicity, whichever comes first.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Breast cancer with evidence of unresectable, locally recurrent or metastatic disease. * Candidate for treatment with paclitaxel.
Exclusion criteria
* Prior chemotherapy in the advanced disease setting. * HER2 positive disease unless previously treated with trastuzumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the combination of SU011248 and paclitaxel | 9/05-7/07 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of each medication | 9/05-7/07 |
| Objective disease response | 9/05-7/07 |
| Progression-free survival. | 9/05-7/07 |
Countries
United States
Outcome results
None listed