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Status:

COMPLETED

A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.

Lead Sponsor:

Institut Claudius Regaud

Conditions:

Advanced Urothelial Cancer

Metastatic Urothelial Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

This is a phase II/III, multicenter, randomized study which includes 420 patients on six years + 3 years follow up. 92 patients will be included during the phase II ; additional 328 patients will be i...

Eligibility Criteria

Inclusion

  • . Age \< or = 18 years, patients aged 75 years or more will benefit from a geriatric assessment.
  • . Advanced or metastatic urothelial cancer confirmed histologically or cytologically.
  • . Patients liable to receive a first -line chemotherapy for advanced or metastatic urothelial carcinoma.
  • . Measurable disease according to RECIST criteria V1.1.
  • . Patients who received neoadjuvant or adjuvant chemotherapy based on platinum salt must have completed treatment at least 6 months before entering the study.
  • . Performance status \< or = 2.
  • . Life expectancy \> 3 months.
  • . Patients with creatinine clearance between 40 and 60 ml / min ( according to Cockcroft and Gault ).
  • . Patients having no contra-indication to overhydration.
  • . Satisfactory hematological tests: Neutrophils \> 1.5 G / l Platelets \> 150 G / l , hemoglobin ≥ 10 g / dl.
  • . Satisfactory liver function tests: total bilirubin \< 1.5 x ULN (upper limit of normal), AST (aspartate aminotransferase) and ALT (alanine aminotransferase)\<or = 2.5 x ULN (or 5 x ULN if liver metastases).
  • . In case of prior radiotherapy, a minimum of 14 days must relapse between the end of radiotherapy and study entry.
  • . For women of childbearing age , use an effective contraceptive method to study entry and for the duration of the study and 6 months after the last dose of study treatment ; For sexually active fertile men having a partner of childbearing age using effective contraception for the duration of the study and 6 months after the last dose of study treatment.
  • . Patient affiliated to a social security system in France.
  • . Patient signed informed consent before inclusion in the study and before any specific procedure for the study.

Exclusion

  • . Any concomitant or previous malignancy within 5 years prior to the study ( with the exception of basal cell or squamous cell carcinoma in situ).
  • . Pregnant or lactating women.
  • . Patients with brain metastases or meningeal or symptoms suggestive of such secondary locations.
  • . Bisphosphonate or Denosumab treatment initiated within 28 days prior to randomization into the study or patient who have started such treatment during the study ( a bisphosphonate or denosumab treatment initiated within a period longer than 28 days before randomization may be continued without change during the study ).
  • . Other concomitant cancer (radiation therapy, radiopharmaceutical agent chemotherapy).
  • . Patients with uncontrolled infection.
  • . Patients with peripheral neuropathy grade\> 1, whatever the origin or patients with hearing loss.
  • . Patient with unstable disease (eg: unstable diabetes, poorly controlled hypertension , congestive heart failure or myocardial infarction within 3 months prior to study entry).
  • . Known hypersensitivity to study drugs.
  • . Treatment with any other investigational drug within 30 days before inclusion.
  • . Any psychological condition , familial, sociological or geographical not to comply with medical monitoring and / or procedures in the study protocol.
  • . Patient protected by law.

Key Trial Info

Start Date :

January 21 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 15 2019

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT02240017

Start Date

January 21 2015

End Date

July 15 2019

Last Update

August 9 2019

Active Locations (18)

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Page 1 of 5 (18 locations)

1

INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Paul Papin

Angers, France, 49933

2

Chru Besancon - Hopital Jean Minjoz

Besançon, France, 25030

3

Institut Bergonie

Bordeaux, France, 33076

4

Centre Francois Baclesse

Caen, France, 14076