A Phase II Study of Intravenous (IV) Vinflunine in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the UrotheliumRevised Protocol #05, incorporating Protocol Amendments 04, 07, 08 and 10;+ Pharmacokinetics Blood Sample Amendment #03 dated 18-Oct-05+ Amendment #06, dated 24-Feb-06
- Conditions
- Advanced Cancer, IV, Nos
- Registration Number
- EUCTR2005-001463-64-SE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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 (+ 2 weeks) 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 2 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
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 or T1b, Gleason score = 6, PSA < 0.5 ng/ml) or in-situ cervical carcinoma or any other tumor with a disease-free interval = 5 years (4.5 years per prior BMS Medical Monitor approval).
5) Prior discontinuation of platinum for reasons of toxicity only.
(Note: patients who switch platinum therapy due to toxicity are eligible if he/she does not progress between platinum agents and the two courses of therapy are considered one treatment regimen.)
6) Receipt of more than one prior chemotherapy regimen in any setting (Note: sequential regimens allowed).
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 major 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.
20) Sexually active fertile men not using effective birth control during the study and up to 6 months after the study if their partners are women of child-bearing potential.
21) Women who are pregnant or breastfeeding
22) Women with a positive pregnancy test on enrollment or prior to study drug administration.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method