A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma TCC of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients who are Ineligible to Receive Cisplatin-Based Therapy - VINCENT

• Conditions: ocally advanced or metastatic Transitional Cell Carcinoma TCC of the urothelium; MedDRA version: 6.1Level: PTClassification code 10061272

• Registration Number: EUCTR2005-003733-40-IT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-03
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1 Provided signed written informed consent Target Population 2 Histologic diagnosis of predominantly locally advanced or metastatic transitional cell carcinoma TCC of the urothelium urinary bladder, kidney, renal pelvis, or ureter ; 3 Ineligibility for cisplatin-based therapy because of at least one of the following two medical conditions - Calculated creatinine clearance Cockroft-Gault formula, see Appendix 3 60 mL/min; or, - New York Heart Association Classification Stage III-IV Congestive Heart Failure see Protocol Appendix 4 ; 4 Measurable disease documented by imaging with at least one uni-dimensional lesion; 5 ECOG performance status of 0, 1, or 2 see Protocol Appendix 5 ; 6 The following laboratory parameters - Absolute Neutrophil Count 1,500 mm3, - Platelet count 100,000 mm3, - Serum total bilirubin 1.5 x upper limit of normal ULN , - Transaminases 2.5 x ULN 5 times ULN only in case of liver metastasis . 7 If patient received neoadjuvant or adjuvant chemotherapy, he/she must have documented relapse, 6 months after the last dose of chemotherapy. Age and Sex 8 Men and women age 18 years of age
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

Sex and Reproductive Status 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 Women who are pregnant or breastfeeding. 4 Women with a positive pregnancy test on enrollment or prior to study drug administration. 5 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. Target Disease Exceptions 6 Diagnosis of predominantly non-transitional cell carcinoma of the urothelium adenocarcinoma, squamous cell carcinoma, small cell, or other or TCC originating at sites other than the urothelium. 7 Patients in whom radiation or surgery is indicated. Medical History and Concurrent Diseases 8 Previous systemic chemotherapy treatment for locally advanced or metastatic disease intravesical treatment is allowed, as well as neoadjuvant and adjuvant chemotherapy that was completed 6 months before documented PD . 9 Known brain metastases or leptomeningeal involvement. CT scans are not required unless there is clinical suspicion of central nervous system CNS disease. 10 National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE v. 3.0 Grade 3 peripheral neuropathy. 11 Prior radiation to 30 of the bone marrow See Protocol Appendix 6 . 12 Other serious illness or medical condition including - Infection requiring systemic anti-infective therapy, - any medical condition that might be aggravated by treatment or which could not be controlled, for instance patients with unstable angina, patients with myocardial infarction within 6 months and/or poorly controlled hypertension. 13 Other malignancies except adequately treated basal carcinoma of the skin, in-situ prostrate cancer Gleason 6, in-situ cervix carcinoma or any other tumor with a disease free interval 5 years. 14 Psychological, familial, or sociological conditions which do not permit medical follow-up and/or compliance with the study protocol. Physical and Laboratory Test Findings 15 Inadequate renal function defined by a serum creatinine clearance 20 mL/min Cockcroft-Gault formula, see Protocol Appendix 3 . Allergies and Adverse Drug Reactions 16 Prior allergic reaction to any vinca alkaloid. Prohibited Therapies and/or Medications 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. Other Exclusion Criteria 19 Prisoners or patients who are compulsorily detained

Study & Design

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