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

NCT02919371 | Unknown Phase 1

• 1 other identifier: 2141-102
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Combined sunitinib and bevacizumab in advanced renal cell carcinoma.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• Bevacizumab maximum tolerated dose, in combination with sunitinib

  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

  12 weeks from enrolling patient # 6

• Assess response rate to the combination of sunitinib and bevacizumab

  response rate is the combination of partial response and complete response

  Through study completion, an average of 6 months

• Assess the progression free survival on the combination of sunitinib and bevacizumab

  Progression free survival will be calculated from time of starting therapy till progression or death whichever comes first

  up to 5 years

Secondary Outcomes (2)

• Overall survival of patients in this regimen

  Participants will be followed for the duration of hospital stay, up to 5 years

• Number of participants with treatment related-adverse effects as assessed by CTCAE v 4.03

  up to 5 years

Study Arms (1)

Sunitinib and Bevacizumab Arm

EXPERIMENTAL

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

Drug: Sunitinib; Drug: Bevacizumab

Interventions

Sunitinib 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

Also known as: Sutent

Sunitinib and Bevacizumab Arm

Bevacizumab DRUG

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

Also known as: Avastin

Sunitinib and Bevacizumab Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

Oncology Centre, King Faisal Specialist Hospital and Research Centre

Riyadh, 11211, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shouki Bazarbashi, MD

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shouki Bazarbashi, MD

CONTACT

00966 11 442 3935; bazarbashi@kfshrc.edu.sa

Fazal Hussain, MD

CONTACT

966-11-4423949; fhussain@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: September 29, 2016
• Study Start: December 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)