Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Feb 2, 2024
  • participants needed
    248
  • sponsor
    Centre Hospitalier Universitaire de Besancon
Updated on 2 April 2021
cancer
calcium
sunitinib
carcinoma
karnofsky performance status
treatment regimen
metastasis
liver metastasis
serum calcium
kidney cancer

Summary

Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will be offered participation in this study during the consultation as part of their usual care. The patients will be included before Sunitinib treatment is started. Thereafter, sunitinib is initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks "on " alternating with 2 weeks "off "

As soon as a dose or schedule adjustment is required, regardless of cause, the patient will be randomised 1/1:

  • Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in accordance with the Marketing Authorisation); 4 weeks "on " alternating with 2 weeks "off "
  • Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen (investigational arm); 2 weeks "on " alternating with 1 week "off "

Details
Condition urinary tract neoplasm, Malignant neoplasm of kidney, Nephropathy, Kidney Disease (Pediatric), Metastatic Renal Cell Carcinoma, Metastatic Renal Cell Cancer, Metastatic Kidney Cancer, Kidney Cancer, Kidney Disease, Renal Cancer, Urologic Cancer, kidney tumor, renal tumors, neoplasia renal, renal neoplasm, renal tumor, kidney tumours, kidney tumors
Treatment Sunitinib
Clinical Study IdentifierNCT02689167
SponsorCentre Hospitalier Universitaire de Besancon
Last Modified on2 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Kidney Cancer or Malignant neoplasm of kidney or Kidney Disease or Metastatic Renal Cell Cancer or urinary tract neoplasm or Renal Cancer or Urologic ...?
Do you have any of these conditions: Renal Cancer or Kidney Disease or renal tumors or Kidney Disease (Pediatric) or Malignant neoplasm of kidney or Metastatic Kidney Cancer or Metastatic...?
Do you have any of these conditions: renal tumor or Metastatic Renal Cell Cancer or Kidney Disease (Pediatric) or kidney tumor or neoplasia renal or renal tumors or Metastatic Renal Cell ...?
Do you have any of these conditions: neoplasia renal or kidney tumors or Metastatic Renal Cell Carcinoma or Malignant neoplasm of kidney or Metastatic Kidney Cancer or Kidney Disease or N...?
Men or women over 18 years old
Patients with local, advanced or inoperable or metastatic (MRCC) renal cell carcinoma who are starting first line treatment with Sunitinib 50mg (4/6 regimen) according to the Marketing Authorisation Indication
Patients with histologically or cytologically confirmed renal cancer, clear cell variant or with a clear cell component
Karnofsky performance status 70%
Adequate organ function
Absolute neutrophil (N) count 1 500 / L
Platelets 100 000 / L
Haemoglobin 10 g/dL
Adjusted serum calcium 2.6 mmol/L
Creatinine clearance 30 mL/min (by the MDRD formula)
Total bilirubin 1.5 x ULN (upper limit of the normal range)
AST 2.5 x ULN and ALT 2.5 x ULN OR AST and ALT 5 x ULN if liver abnormalities due to liver metastases AST = aspartate aminotransferase ALT = alanine aminotransferase

Exclusion Criteria

Renal carcinoma with no clear cell component
Previous systemic treatment for the RCC regardless of type (including targeted therapy, immunotherapy, chemotherapy, hormone or experimental therapy). Previous or concomitant treatment with a bisphosphonate or denosumab is allowed
Patients whose clinical state and comorbidities are not consistent with administration of Sunitinib at the initial dose of 50mg/day 4 weeks out of 6
Grade 3 haemorrhage within 4 weeks before starting treatment with Sunitinib (according to the NCI-CTCAE toxicity score version 3.0)
The presence of a past history of cancer in the 3 years before inclusion into the study
Major surgery within 4 weeks before sunitinib initiation
Past history of symptomatic cerebral metastases, spinal cord compression or meningeal carcinomatosis. Patients with cerebral metastases discovered incidentally on imaging and who are asymptomatic are not excluded if these metastases have been treated (radiotherapy and/or surgery) with a period of at least 4 weeks between the end of treatment and inclusion into the study and no clinical or radiological signs of relapse, and corticosteroid dose is not exceeding 10mg/day of prednisone or equivalent. Subjects will be excluded if subjects have signs of grade 2 treatment-related complications
Any of the following features within 6 months of the administration of Sunitinib: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack
Pulmonary embolism or deep vein thrombosis within 3 months of inclusion (unless it's stable, asymptomatic and treated with a low molecular weight heparin for at least 6 weeks before inclusion)
Any known acute or chronic disorder (such as severe chronic obstructive pulmonary disease) which in the opinion of the investigator could impact on the patient's capacity to receive the study treatment or make interpretation of toxicity or adverse events difficult
Known HIV infection
History of chronic active hepatitis including subjects who are carriers of the hepatitis B (HBV) or hepatitis C (HCV) virus
Existence of uncontrolled infection
Uncontrolled hypertension defined as a blood pressure of > 150 mmHg systolic or > 100 mmHg diastolic despite optimal anti-hypertensive therapy (blood pressure must be controlled at inclusion)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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