Neoplasms
Conditions
Brief summary
The purpose of this study is to test SU011248 (sunitinib) in combination with paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor activity.
Interventions
DRUGcarboplatin + SU011248 (sunitinib) + paclitaxel
AUC of 6 mg\*min/mL administered as a 30-minute infusion, every 21 days for 4 cycles or until progression/unacceptable toxicity. 25 mg, 37.5 mg, or 50 mg (depending on the dose level assigned) orally taken every day or for 2 weeks and 1 week off without for 4 cycles or until progression/unacceptable toxicity. 175 mg/m2, 200 mg/m2, or 225 mg/m2 (depending on the dose level assigned), administered as a 3-hour infusion every 21 days for 4 cycles or until progression/unacceptable toxicity.
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
* Histologically or cytologically proven diagnosis of any advanced solid malignancy that is not amenable to treatment with curative intent * Candidates for treatment with carboplatin and paclitaxel with maximum of 2 prior chemotherapy regimens * ECOG performance status 0 or 1
Exclusion criteria
* Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target, metastatic lesions * Diagnosis of any second malignancy within the past 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the maximum tolerated dose (MTD) and overall safety of SU011248 when administered in combination with paclitaxel/carboplatin in patients with advanced solid tumors (ongoing) | 3 yrs |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate pharmacokinetic parameters of carboplatin, paclitaxel, SU011248 and its active metabolite, SU012662. Assess antitumor activity of the combination. | 3 yrs |
Countries
United States
Outcome results
None listed