A Trial With Vinflunine in Patients With Metastatic Bladder Cancer and Impaired Renal Function

Phase 2

Completed

• Conditions: Renal Pelvis Cancer; Ureter Cancer; Urothelial Carcinoma; Bladder Cancer; Urethra Cancer
• Interventions: Drug: Vinflunine; Drug: Gemcitabine; Drug: Carboplatin

• Registration Number: NCT02665039
• Lead Sponsor: Dr Anders Ullén

Brief Summary

This study aim to compare the efficacy, safety and quality of life of vinflunine/gemcitabine and carboplatin/gemcitabine in patients with metastatic urothelial cancer and impaired renal function.

Detailed Description

Rational The standard first line treatment for patients with metastatic urothelial carcinoma unfit for cisplatin due to renal impairment is carboplatin containing chemotherapy, with a median overall survival of approximately 8-10 month. New, more effective regimens in terms of tumor control and quality of life are urgently needed. Vinflunine has proven efficacy in urothelial carcinoma and is registered as second line treatment. The combination of gemcitabine and vinflunine has not yet been evaluated in first line treatment for patients with metastatic urothelial carcinoma.

Objectives

* To compare the progression free survival (FPS) of vinflunine/gemcitabine versus carboplatin/gemcitabine in patients with locally advanced or metastatic transitional cell carcinoma of the urothelial tract unfit for cisplatin based chemotherapy due to impaired renal function.

* To evaluate the tumour response (ORR), overall survival (OS) and disease control rate (DCR) of vinflunine/gemcitabine versus carboplatin/gemcitabine

* To assess the safety and toxicity of vinflunine/gemcitabine versus carboplatin/gemcitabine.

* To investigate and compare Quality of life during treatment with vinflunine/gemcitabine and carboplatin/gemcitabine respectively.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-27
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vinflunine + gemcitabine	Vinflunine	Vinflunine will be given intravenously once every 21 days, starting at a dose of: * 280 mg/m2 in patients with GFR 40-60 ml/min * 250 mg/m2 in patients aged \>80 years and/or GFR 30-40 ml/min Gemcitabine will be given intravenously on day 1 and day 8 of every 21 day cycle, starting at a dose of 1000 mg/m2
Vinflunine + gemcitabine	Gemcitabine	Vinflunine will be given intravenously once every 21 days, starting at a dose of: * 280 mg/m2 in patients with GFR 40-60 ml/min * 250 mg/m2 in patients aged \>80 years and/or GFR 30-40 ml/min Gemcitabine will be given intravenously on day 1 and day 8 of every 21 day cycle, starting at a dose of 1000 mg/m2
Carboplatin + gemcitabine	Gemcitabine	Carboplatin will be given intravenously once every 21 days, starting at a dose of AUC 4.5 Gemcitabine will be given intravenously on day 1 and day 8 of every 21 day cycle, starting at a dose of 1000 mg/m2
Carboplatin + gemcitabine	Carboplatin	Carboplatin will be given intravenously once every 21 days, starting at a dose of AUC 4.5 Gemcitabine will be given intravenously on day 1 and day 8 of every 21 day cycle, starting at a dose of 1000 mg/m2

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	From randomization through study completion, on average within 9 months	Defined as the duration from randomization to either confirmed progression (by RECIST) or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR = CR + PR)	From randomization through study completion, on average within 9 months	Defined as best confirmed response according to RECIST through study completion from randomization to either confirmed progression (by RECIST) or death from any cause
Overall survival (OS)	From randomization to death from any cause, on average within 18 months	Defined as the duration from randomization to death from any cause or last follow-up.
Disease control rate, DCR (=CR + PR + SD)	From randomization through study completion, on average within 9 months	Defined as the percentage of patients who have achieved complete response, partial response and stable disease according to RECIST through study completion from randomization to either confirmed progression (by RECIST) or death from any cause
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0	From the date the informed consent is signed up to 30 days after the last dose	Treatment-related adverse events will be assessed by CTCAE v4.0. The safety profile and tolerability of vinflunine + gemcitabine compared to carboplatin + gemcitabine will be determined from the number of Adverse Events reported.
Quality of Life (QoL) assessed by QLQ-C30	From the date the informed consent is signed up to 30 days after the last dose	Quality of Life will be assessed by the EORTC Quality of Life Questionnaire C30 (QLQ-C30) Version 3.0. The QoL for patients treated with vinflunine + gemcitabine will be compared to patients treated with carboplatin + gemcitabine

Trial Locations

Locations (2)

Department of Oncology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Department of Oncology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden