Advanced Cancer, IV, Nos
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provided signed written informed consent. 2) Histologic diagnosis of predominantly locally advanced or metastastic transitional cell carcinoma (TCC) of the urothelium (urinary bladder, kidney, renal pelvis, or ureter) (NOTE: rare foci of other histologies are acceptable). 3) At the time of study entry, patient must no longer be a candidate for local/regional control of disease (surgery and/or radiotherapy, see Protocol Appendix 1 for reference). 4) Patients must have received at least two cycles of prior cisplatin at a dose of least 60 mg/m2 or prior carboplatin at a dose of at least AUC 4 (or equivalent) in any setting. (NOTE: subsequent cycles of cisplatin or carboplatin, if delivered, need not be 60 mg/m2 or AUC 4, respectively). 5) Measurable disease documented by imaging with at least one bidimensional lesion (See Protocol Section 3.3.2) 6) Documented relapse or progressive disease within 12 months after the last dose of a platinum containing regimen in any setting at the time of study entry. 7) Karnofsky Performance Status of 100, 90, or 80 (See Protocol Appendix 2) 8) Recovery from toxicity due to prior therapy (i.e. toxicity has resolved to baseline or is deemed irreversible). At least 4 weeks must have elapsed since last dose of chemotherapy (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin), immunotherapy, or radiotherapy and the beginning of protocol therapy. 9) Men and women = age 18 WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the study. 2) WOCBP using a prohibited contraceptive method. 3) Diagnosis of predominantly non-transitional cell carcinoma of the urothelium (adenocarcinoma, squamous cell carcinoma, small cell, or other). 4) Diagnosis of other malignancies except adequately treated basal cell carcinoma of the skin, incidental prostate cancer (T1a, Gleason score 6, PSA 1.5 times the upper limit of normal (ULN) or transaminases (ALT, AST) level > 2.5 times the ULN (> 5 times the ULN only in case of liver metastasis). 15) Inadequate renal function defined by a serum creatinine clearance < 40 ml/min (Cockcroft-Gault formula, see Protocol Appendix 4). 16) Prior allergic reaction to any vinca alkaloid. 17) Patients who require treatment with ketoconazole, itraconazole, ritonavir, amprenavir and indinavir. 18) Any concurrent chronic systemic immune therapy (including steroids), chemotherapy, radiation therapy, hormonal therapy (except for physiologic replacement), or any other investigational agent. 19) Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the objective response rate (as defined by the WHO criteria modified by the SWOG) in patients with TCC receiving vinflunine, who have had documented progression within 12 months after the last dose of a platinum-containing regimen and are not candidates for cystectomy.;Secondary Objective: 1) To estimate duration of response. 2) To estimate time to response. 3) To estimate disease control rate (Complete Response + Partial Response + Stable Disease). 4) To estimate progression free survival. 5) To estimate overall survival. 6) To evaluate the safety profile of vinflunine.;Primary end point(s): Efficacy: The primary efficacy analysis will be based on response rate, as determined by the Independent Response Review Committee (IRRC), where tumor response rate is defined as the total number of complete and partial responders divided by the total number of treated patients. Safety: The analysis of safety will be based on the frequency of adverse events and their severity for patients who received at least one cycle of vinflunine. Worst toxicity grades per patient will be tabulated for adverse events and laboratory measurements. | — |
Countries
Austria, Italy, Spain, Sweden
Outcome results
None listed