Impact of kidney function on cancer drug levels in patients with metastatic kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how chronic renal failure affects the blood concentration of the kinase inhibitors pazopanib and cabozantinib in patients with metastatic kidney cancer. It involves blood sampling at 1 month and 3 months after starting treatment to assess drug efficacy and toxicity based on the patient's renal function. The study aims to determine if dose adjustments are necessary to improve treatment outcomes for patients with varying degrees of renal failure. Regular follow-ups and compliance with treatment are essential for accurate assessment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient followed for metastatic clear cell renal cell carcinoma.
2. Age ≥18 years old.
3. Performance Status (PS) according to Eastern Cooperative Oncology Group (ECOG) = 0, 1 or 2
4. Patient treated with a VEGF-R inhibitor: pazopanib or cabozantinib for metastatic kidney cancer.
5. If patient doesn't have renal failure -\> group 1, or if patient has chronic renal failure according to the moderate stage Chronic Kidney Disease - Epidemiology (CKD-EPI) formula (Clr \<60 ml / min, stage 3) -\> group 2, or if patient have chronic renal failure according to the CKD-EPI formula of severe or terminal stage (Clr \<30 ml / min, stage 4 and stage 5), with or without dialysis -\> group 3.
6. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
7. Patient having given informed, written and express consent.
8. Affiliation to the French Social Security System.

Exclusion Criteria:

1. Indication other than clear cell renal cell carcinoma for these same ITKs
2. Pregnant or breast-feeding subjects
3. Patient whose regular follow-up is impossible for psychological, family, social or geographic reasons,
4. Patient under guardianship, curatorship or safeguard of justice
5. Participation in another clinical study with a research product during the last 30 days before inclusion.

Where it's running

• APHM Hôpital LA TIMONE
  Marseille, France Recruiting
• CHU Montpellier - Hôpital St Eloi
  Montpellier, France Recruiting
• ICM Val d'Aurelle
  Montpellier, France Recruiting
• CHU de Nîmes, Institut de Cancérologie du Gard
  Nîmes, France Recruiting
• Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Fanny LEENHARDT, Dr — Institut du Cancer de Montpellier (ICM)
• Study coordinator: Aurore MOUSSION
• Email: DRCI-icm105@icm.unicancer.fr
• Phone: 04 67 61 31 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.