A Phase II Study of Intravenous (IV) Vinflunine in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the UrotheliumRevised Protocol #01, version 2.0 incorporating Protocol Amendment #04, andPharmacogenetics Blood Sample Amendment #01, dated 18-Oct-04Primary Tumor Tissue Sample Amendment #02, dated 18-Oct-04Pharmacokinetics Blood Sample Amendment #03, dated 18-Oct-04

• Conditions: Advanced Cancer, IV, Nos

• Registration Number: EUCTR2005-001463-64-AT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-06
• Last Update Posted: 6 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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

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 < 0.5 ng/ml) or in-situ cervical carcinoma or any other tumor with a disease-free interval = 5 years.
5) Prior discontinuation of platinum for reasons of toxicity only.
6) Receipt of more than one prior chemotherapy regimen in any setting.
7) Known brain metastases or leptomeningeal involvement. CT scans are not required to rule this out unless there is clinical suspicion of central nervous system (CNS) disease.
8) CTC (v.2.0) = Grade 2 peripheral neuropathy.
9) Prior radiation to = 30% of the bone marrow. (See Protocol Appendix 3)
10) A serious uncontrolled medical disorder, recent abdominal surgery or active infection which would impair the ability of the patient to receive protocol therapy
11) Concurrent heart failure (New York Heart Association Class III - IV) or unstable
angina, myocardial infarction within the prior 6 months, or poorly controlled hypertension
12) Psychological, familial, or sociological conditions that do not permit medical
follow-up and/or compliance with the study protocol.
13) Inadequate hematologic function defined by an absolute neutrophil count (ANC)
< 1,500 cells/mm3 or a platelet count < 100,000 cells/mm3.
14) Inadequate hepatic function defined by a total bilirubin level > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified