Combined Alternating Sunitinib and Bevacizumab (Avastin ) in Advanced Renal Cell Carcinoma (CASA)

  • STATUS
    Recruiting
  • End date
    Dec 22, 2021
  • participants needed
    77
  • sponsor
    King Faisal Specialist Hospital & Research Center
Updated on 22 January 2021
platelet count
cancer
monoclonal antibodies
sunitinib
measurable disease
carcinoma
avastin
growth factor
kinase inhibitor
metastasis
neutrophil count
bevacizumab
primary tumor
brain metastases
brain metastasis
solid tumour
renal function tests
advanced renal cell carcinoma

Summary

Combined sunitinib and bevacizumab in advanced renal cell carcinoma.

Description

This is a phase I/II trial of combined sunitinib and bevacizumab in advanced renal cell carcinoma ( CASBA) where Bevacizumab will be used only on day 29 of each 6 weeks sunitinib cycle.

Details
Condition Adenocarcinoma, Malignant neoplasm of kidney, Renal Cell Carcinoma, Kidney Cancer, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, clear cell renal cell carcinoma
Treatment bevacizumab, Sunitinib
Clinical Study IdentifierNCT02919371
SponsorKing Faisal Specialist Hospital & Research Center
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Gender: Male or Female
Do you have Renal Cell Carcinoma?
Do you have any of these conditions: Kidney Cancer or Renal Cell Cancer or Malignant neoplasm of kidney or Malignant Adenoma or clear cell renal cell carcinoma or Renal Cell Carcinoma or ...?
Histologically confirmed renal cell carcinoma with clear cell histology ( mixed histology with clear cell component is accepted)
Patient should have either locally advanced or metastatic disease
No prior anti-cancer therapy
Age 18 years
Life expectancy of 3 months or more
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
Performance status 0-2 by ECOG scale
Patients with controlled brain metastasis are accepted
Adequate renal function: serum creatinine 2 times the institutional upper limit of normal
Adequate hepatic function: total bilirubin within normal institutional limits, serum AST and ALT levels 2 times the institutional upper limit of normal or 5 times the institutional upper limit of normal of elevated because of liver involvement
Coagulation (PT 1.5 times the institutional upper limit of normal)
Adequate hematological values: leukocyte count 3.0 x 109/L, an absolute neutrophil count 1.5 x 109/L, a platelet count 100 x 109/L and hemoglobin 9.0 g/dL
Urine dipstick for proteinuria <1+, patients discovered to have 1+ on dipstick urinanalysis at baseline should have urine protein/urine creatinine ratio 1
Singed written informed consent before enrolment
Patient should have unresectable disease ( for both the primary tumor and the metastasis)

Exclusion Criteria

Inability to comply with the protocol therapy
Uncontrolled hypertension defined as BP more than 160 systolic and or more than 100 diastolic despite adequate treatment at the time of treatment initiation
Severe cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction, significant arrhythmias or Transient ischemic attack (TIA) or cerebrovascular accident (CVA) in the last 6 months
Major bleeding disorder, significant traumatic injury or recent major surgery within 28 days of starting therapy. Or minor surgery (FNA/Core biopsy) within 7 days of starting therapy
History of abdominal abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
Pre-existing thyroid abnormality
Concurrent proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, bepridil, haloperidol, risperidone, indapamide and flecainide
Recent significant hemoptysis (1/2 tea spoon red blood within last month)
Concurrent medication that either CYP 450 3A4 inducers or inhibitors
Concurrent use of proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide
Pregnancy or breast feeding, or patient refusal to use appropriate contraception for female patients in childbirth age
Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer
Psychiatric or mental disorder, precluding understanding of the information of the trial related topics and giving valid informed consent
Any psychological, familial, geographic or social circumstances which could impair the patient ability to participate in the trial and comply with follow up
Any circumstance which might impair the patient's ability to comply with an out-patient regimen
Active uncontrolled infection
Serious underlying medical condition (in the judgment of the investigator) which could impair the ability of the patient to participate in the trial
Treatment with other experimental drugs within 30 days of entry into the trial
Treatment with other anti-cancer therapy
Legal incapacity
Significant proteinuria (urine protein: creatinine ratio > 1.0)
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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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