Efficacy Study of Sunitinib and Everolimus (Rotational vs Sequential Arm) in Pats. With m Clear Cell Renal Cancer (SUNRISES)

September 29, 2017 updated by: Associació per a la Recerca Oncologica, Spain

Randomized ph. II Study to Explore Efficacy and Feasibility of Upfront Rotations Between SUNitinib and Everolimus vs Sequential Treatment of 1st lIne Sunitinib & 2nd Line EverolimuS Until Progression in Pats Met. Clear Cell Renal Cancer

The objective of this study is to assess the progression-free survival, of patients who receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a first line treatment followed by everolimus when progression occurs.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, randomized phase II study to investigate the feasibility of alternating cycles of treatment with sunitinib and everolimus compared to sequential treatment of sunitinib followed by everolimus.

The study population consists of adult patients (over 18 years old) with clear cell mRCC (Metastatic Renal Cell Cancer) who have not received prior therapy for their metastatic disease.

The purpose of the study is to determine the progression free survival, feasibility and safety profile of the experimental arm compared to standard of care.

In the experimental arm alternating treatment will consist of repeating cycles of 24 weeks of treatment consisting of 12 weeks of sunitinib 4weeks on 2 weeks off, 50 mg pd followed by 12 weeks of everolimus 10 mg per day 11 weeks on 1 week off in patients with metastatic clear cell renal cancer. The comparative arm will be the standard regimen of sunitinib (50 mg pd 4/2) until progression, followed thereafter by everolimus (10 mg per day continuously, 11/1) until progression.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Hopital Bordeaux University
  • Greece
      • Athens, Greece, 11528
        • Alexandra General Hospital of Athens
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28026
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28050
        • Clara Campal. Hospital Sanchinarro
      • Málaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Valencia, Spain
        • Hospital General Universitario de Valencia
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Hospital Universitario Central de Asturias
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Marques de Valdecilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Renal cell carcinoma with a predominant clear cell component confirmed by histology.
  • Advanced disease: metastatic AND, not suitable for resection
  • Male or female, aged 18 years or older
  • ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1

  • Low or intermediate MSKCC (Memorial Sloan Kettering Cancer Center) prognostic risk score,i.e. no more than 2 of the following:

    • Karnofsky performance status (<80%)
    • Low serum hemoglobin (≤ 13 g/dL for males and ≤ 11.5 g/dL for females)
    • High corrected serum calcium (≥ 10 mg/dL)
  • Target and/or non-target lesions according to RECIST 1.1 ( Response Evaluation Criteria in Solid Tumors)
  • Expected survival of at least 3 months.
  • No prior systemic treatment. But adjuvant treatment is ok if stopped from ≥ 24 months
  • Adequate bone marrow function as shown by:
  • Adequate liver function as shown by:
  • Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN (upper limit of normal)
  • Left ventricular ejection fraction ≥55% on gated cardiac blood pool scan, or normal left ventricular function and fractional shortening on echocardiogram (according to institutional limits).

  • SBP (systolic blood pressure) ≤140mmHg and DBP (diastolic blood pressure)

    • 90mmHg (it is acceptable to initiate antihypertensive treatment prior to registration to achieve these goals).
  • Able to commence treatment within 7 days of registration.
  • Willing and able to comply with follow-up and all other protocol requirements.
  • Written informed consent

Exclusion Criteria:

  • Prior treatment with VEGF-targeting agents or multi-kinase inhibitors or mTOR-targeting agents
  • Active central nervous system metastases.
  • Other malignancy diagnosed within the last 5 years, except the following if adequately treated: superficial squamous cell carcinoma or basal cell carcinoma of skin, superficial bladder cancer (T1 and G1 or T1 and G2), stage 1 cervical cancer.
  • Treatment with an investigational agent in the last 4 w.
  • Known to be HIV positive.
  • Evidence of chronic hepatitis due to hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Clinically significant heart disease (NYHA Class III or IV)
  • History of hypertension requiring hospitalization.
  • Other serious illnesses,
  • Immunotherapy or chemotherapy in the last 4 w (6 weeks for nitrosoureas)
  • Major surgery in the last 4 w, or planned in the next 6 w
  • Radiation therapy in the last 2 w, or planned in the next 6 w
  • NCI CTCAE (Common Toxicity Criteria for Adverse Effects) version 4.0 grade 3 or worse hemorrhage in last 4 w.
  • Any of the following in the last year: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
  • Ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 grade ≥2, atrial fibrillation of any grade, or prolongation of the corrected QT interval (QTc) to >450 msec for males or >470 msec for females
  • Uncontrolled diabetes as defined by fasting serum glucose >1.5 X ULN.
  • Pregnancy,lactation. Inadequate contraception.
  • Known allergy or hypersensitivity to everolimus, sunitinib or iodine.
  • Medical or psychiatric condition that compromises the patient's ability to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotational arm
Alternating cycles of treatment with sunitinib and everolimus; repeating cycles of 24 weeks of treatment consisting of 12 weeks of sunitinib 4weeks on 2 weeks off, 50 mg pd followed by 12 weeks of everolimus 10 mg per day 11 weeks on 1 week off in patients with metastatic clear cell renal cancer.
Drug: Sunitinib
50 mg pd
Other Names:
  • SUTENT
Drug: Everolimus
10 mg pd
Other Names:
  • AFINITOR
Active Comparator: Sequential arm
The comparative arm will be the standard regimen of sunitinib (50 mg pd 4/2) until progression, followed thereafter by everolimus (10 mg per day continuously, 11/1) until progression.
Drug: Sunitinib
50 mg pd
Other Names:
  • SUTENT
Drug: Everolimus
10 mg pd
Other Names:
  • AFINITOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS) rate 1 year
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
PFS of rotational arm versus PFS of the 2 lines in control arm
Time Frame: From date of randomization until the date of first documented progression assesed up to 30 months
From date of randomization until the date of first documented progression assesed up to 30 months
Overall Survival
Time Frame: From the date of the tratment start to the date of death or the last contact for alived patients at the momment of data censored. Assesed up to 30 months
From the date of the tratment start to the date of death or the last contact for alived patients at the momment of data censored. Assesed up to 30 months
Safety Profile
Time Frame: From the first treatment dose until 28 days after study treatment discontinuation. Assesed up to 30 months
From the first treatment dose until 28 days after study treatment discontinuation. Assesed up to 30 months
Objective tumor response rate per arm
Time Frame: From the date of first tumor response to the date of progression or start date of other cancer therapy. Assesed up to 30 months
From the date of first tumor response to the date of progression or start date of other cancer therapy. Assesed up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associació per a la Recerca Oncologica, Spain

Collaborators

Novartis
Pivotal S.L.

Investigators

  • Principal Investigator: Joaquim Bellmunt, MD/PhD, Associacio Per la Recerca Oncológica (APRO)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2013

Primary Completion (Actual)

May 8, 2017

Study Completion (Actual)

May 8, 2017

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 6, 2013

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUNRISES STUDY (CRAD001LIC34T)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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