CompletedPhase 2

JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin

France69 participantsStarted 2011-02

Plain-language summary

This study is assessing the combination of well known cytotoxics with a novel anti-cancer agent that could be administered as monotherapy without renal toxicity in patients with renal impairment presenting with advanced or metastatic urothelial carcinoma previously treated with a platinum-based regimen. The intent of this study is to clarify the benefit/risk ratio of the two most promising associations of cytotoxics including the novel therapeutic agent, vinflunine: vinflunine-gemcitabine and vinflunine-carboplatin.

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Man or woman aged ≥ 18 years and \< 80 years * Signed written informed consent * Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCCU) * Ineligibility for cisplatin-based therapy because of at least one of the following two medical conditions: * Calculated creatinine clearance (Cockcroft-Gault formula)\< 60 mL/min * New York Heart Association Classification Stage II-III Congestive Heart Failure (documented by medical history) * "Measurable" disease with at least one uni-dimensional lesion according to RECIST guideline (version 1.1) * ECOG performance status of 0 or 1 * Estimated life expectancy of at least 12 weeks * Patient without prior systemic anticancer therapy unless if it had been administered as neoadjuvant or adjuvant chemotherapy (CT) for TCCU and if the patient has documented relapse ≥ 6 months after the last dose of CT (prior intravesical CT allowed) * Adequate bone marrow and hepatic functions as evidenced by: * Absolute Neutrophil Count ≥ 2,000/mm3 (≥ 2.0 x 109/L) * Haemoglobin ≥ 10 g/dL * Platelet count ≥ 100,000/mm3 * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Transaminases ≤ 2.5 x ULN \[≤ 5 x ULN only in case of liver metastasis\] * Absence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be assessed wi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disease control rate as defined by RECIST criteria (version 1.1) as a percentage of best overall responses of Complete (CR) + Partial (PR) + Stable Disease (SD) for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations

Timeframe: Change from baseline in tumor assessment at 12 weeks (cycle 4)

Trial details

NCT IDNCT01599013

SponsorPierre Fabre Medicament

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-10

View on ClinicalTrials.gov More Bladder Transitional Cell Carcinoma Stage IV trials