This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone combined with carboplatin in adult patients with advanced solid tumors who progressed despite standard therapy or for whom no standard therapy exists or who might benefit from treatment with carboplatin
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Norwalk Hospital
Norwalk, Connecticut, United States
Associates in Oncology
Rockville, Maryland, United States
Wertz Clinical Cancer Center (Wayne State University)
Detroit, Michigan, United States
Siteman Cancer Center (Washington University School of Medicine)
St Louis, Missouri, United States
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6)
Time frame: Every 3 weeks
Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations
Time frame: Every 6 weeks
Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors)
Time frame: Every 6 weeks
Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response
Time frame: Every 6 weeks
Pharmacokinetic profile of patupilone combined with carboplatin
Time frame: First 6 weeks (cycle 1 & 2 only)
Relationship between pharmacokinetics and clinical outcome
Time frame: Every 6 weeks during cycle 1 & cycle 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cancer Research and Treatment Center (University of New Mexico)
Albuquerque, New Mexico, United States