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

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ClinicalTrials.gov Identifier: NCT02919371
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center

Brief Summary:
Combined sunitinib and bevacizumab in advanced renal cell carcinoma.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Sunitinib Drug: Bevacizumab Phase 1 Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Combined Alternating Sunitinib and Bevacizumab (Avastin®) in Advanced Renal Cell Carcinoma (CASA)
Study Start Date : December 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sunitinib and Bevacizumab Arm
Phase I/II Combined Alternating Sunitinib and Bevacizumab (Avastin®) in Advanced Renal Cell carcinoma (CASA)Combined Alternating Sunitinib and Bevacizumab
Drug: Sunitinib
Oral therapy ( Anti-vascular endothelial growth factor Tyrosin Kinase Inhibitor): given as 50 mg daily from day 1 to day 28- cycle repeated every 42 days
Other Name: Sutent

Drug: Bevacizumab
Monoclonal antibody against vascular endothelial growth factor: given intravenously on day 29 of each sunitinib cycle
Other Name: Avastin




Primary Outcome Measures :
  1. Bevacizumab maximum tolerated dose, in combination with sunitinib [ Time Frame: 12 weeks from enrolling patient # 6 ]
    This is the phase I part of the study. patient will enroll on Bevacizumab dose of 5 mg/kg body weight. If no dose limiting toxicity in 1st 6 patients, the dose will be escalated to 10 mg/kg in the remainder of the patients

  2. Assess response rate to the combination of sunitinib and bevacizumab [ Time Frame: Through study completion, an average of 6 months ]
    response rate is the combination of partial response and complete response

  3. Assess the progression free survival on the combination of sunitinib and bevacizumab [ Time Frame: up to 5 years ]
    Progression free survival will be calculated from time of starting therapy till progression or death whichever comes first


Secondary Outcome Measures :
  1. Overall survival of patients in this regimen [ Time Frame: Participants will be followed for the duration of hospital stay, up to 5 years ]
    Overall survival will be calculated from date of start on therapy till death

  2. Number of participants with treatment related-adverse effects as assessed by CTCAE v 4.03 [ Time Frame: up to 5 years ]
    toxicity will be graded according to the NCI-CTC version 4.03



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed renal cell carcinoma with clear cell histology ( mixed histology with clear cell component is accepted)
  2. Patient should have either locally advanced or metastatic disease
  3. No prior anti-cancer therapy
  4. Age ≥ 18 years
  5. Life expectancy of 3 months or more
  6. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
  7. Performance status 0-2 by ECOG scale
  8. Patients with controlled brain metastasis are accepted
  9. Adequate renal function: serum creatinine ≤ 2 times the institutional upper limit of normal
  10. 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
  11. Coagulation (PT ≤ 1.5 times the institutional upper limit of normal)
  12. 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
  13. Urine dipstick for proteinuria <1+, patients discovered to have ≥ 1+ on dipstick urinanalysis at baseline should have urine protein/urine creatinine ratio ≤1
  14. Singed written informed consent before enrolment
  15. Patient should have unresectable disease ( for both the primary tumor and the metastasis)

Exclusion Criteria:

  1. Inability to comply with the protocol therapy
  2. Uncontrolled hypertension defined as BP more than 160 systolic and or more than 100 diastolic despite adequate treatment at the time of treatment initiation.
  3. 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
  4. 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
  5. History of abdominal abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
  6. Pre-existing thyroid abnormality
  7. Concurrent proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, bepridil, haloperidol, risperidone, indapamide and flecainide
  8. Recent significant hemoptysis (1/2 tea spoon red blood within last month)
  9. Concurrent medication that either CYP 450 3A4 inducers or inhibitors
  10. Concurrent use of proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide
  11. Pregnancy or breast feeding, or patient refusal to use appropriate contraception for female patients in childbirth age
  12. Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer
  13. Psychiatric or mental disorder, precluding understanding of the information of the trial related topics and giving valid informed consent
  14. Any psychological, familial, geographic or social circumstances which could impair the patient ability to participate in the trial and comply with follow up.
  15. Any circumstance which might impair the patient's ability to comply with an out-patient regimen
  16. Active uncontrolled infection
  17. Serious underlying medical condition (in the judgment of the investigator) which could impair the ability of the patient to participate in the trial
  18. Treatment with other experimental drugs within 30 days of entry into the trial
  19. Treatment with other anti-cancer therapy
  20. Legal incapacity
  21. Significant proteinuria (urine protein: creatinine ratio > 1.0)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919371


Contacts
Contact: Shouki Bazarbashi, MD 00966 11 442 3935 bazarbashi@kfshrc.edu.sa
Contact: Fazal Hussain, MD 966-11-4423949 fhussain@kfshrc.edu.sa

Locations
Saudi Arabia
Oncology Centre, King Faisal Specialist Hospital and Research Centre Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Shouki Bazarbashi, MD    00966 11 442 3935    bazarbashi@kfshrc.edu.sa   
Contact: Fazal Hussain, MD    966-11-4423949    fhussain@kfshrc.edu.sa   
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Shouki Bazarbashi, MD King Faisal Specialist Hospital

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT02919371     History of Changes
Other Study ID Numbers: 2141-102
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No- unless the data are so encouraging then this can be done

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bevacizumab
Sunitinib
Endothelial Growth Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents