Advanced Solid Tumors, Non Small Cell Lung Cancer
Conditions
Keywords
advanced solid tumors, non small cell lung cancer, pulmonary neoplasms, sunitinib (SUTENT), docetaxel (Taxotere), Angiogenesis Inhibitors
Brief summary
This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.
Interventions
DRUGsunitinib
25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off)
DRUGdocetaxel
60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion
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
Advanced solid tumor malignancy ECOG 0 or 1
Exclusion criteria
Prior treatment with with high-dose chemotherapy requiring stem cell rescue Prior irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) Patients with centrally located lung lesions unless recently treated with radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities | November 2007 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel. | November 2007 |
| Objective disease response | November 2007 |
Countries
United States
Outcome results
None listed