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

NCT ID: NCT02919371

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2021-12-31

Brief Summary

Combined sunitinib and bevacizumab in advanced renal cell carcinoma.

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sunitinib and Bevacizumab Arm

Phase I/II Combined Alternating Sunitinib and Bevacizumab (Avastin®) in Advanced Renal Cell carcinoma (CASA)Combined Alternating Sunitinib and Bevacizumab

Group Type: EXPERIMENTAL

Sunitinib

Intervention Type: DRUG

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

Bevacizumab

Intervention Type: DRUG

Monoclonal antibody against vascular endothelial growth factor: given intravenously on day 29 of each sunitinib cycle

Interventions

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

Intervention Type: DRUG

Bevacizumab

Monoclonal antibody against vascular endothelial growth factor: given intravenously on day 29 of each sunitinib cycle

Intervention Type: DRUG

Other Intervention Names

Sutent; Avastin

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shouki Bazarbashi, MD

Role: PRINCIPAL_INVESTIGATOR

King Faisal Specialist Hospital & Research Center

Locations

Oncology Centre, King Faisal Specialist Hospital and Research Centre

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Shouki Bazarbashi, MD

Role: CONTACT

bazarbashi@kfshrc.edu.sa

00966 11 442 3935

Fazal Hussain, MD

Role: CONTACT

fhussain@kfshrc.edu.sa

966-11-4423949

Facility Contacts

Shouki Bazarbashi, MD

Role: primary

bazarbashi@kfshrc.edu.sa

00966 11 442 3935

Fazal Hussain, MD

Role: backup

fhussain@kfshrc.edu.sa

966-11-4423949

Other Identifiers

2141-102

Identifier Type: -

Identifier Source: org_study_id