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

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ClinicalTrials.gov Identifier: NCT01784978
Recruitment Status : Terminated (Lack of recruitment)
First Posted : February 6, 2013
Last Update Posted : October 2, 2017
Sponsor:
Collaborators:
Novartis
Pivotal S.L.
Information provided by (Responsible Party):
Associació per a la Recerca Oncologica, Spain

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: Sunitinib Drug: Everolimus Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 12, 2013
Actual Primary Completion Date : May 8, 2017
Actual Study Completion Date : May 8, 2017


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 Name: SUTENT

Drug: Everolimus
10 mg pd
Other Name: 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 Name: SUTENT

Drug: Everolimus
10 mg pd
Other Name: AFINITOR




Primary Outcome Measures :
  1. Progression-free survival (PFS) rate 1 year [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Safety Profile [ Time Frame: From the first treatment dose until 28 days after study treatment discontinuation. Assesed up to 30 months ]
  4. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

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): NCT01784978


Locations
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France
Hopital Bordeaux University
Bordeaux, France
Greece
ALEXANDRA General Hospital of Athens
Athens, Greece, 11528
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitario 12 de Octubre
Madrid, Spain, 28026
Hospital Clínico San Carlos
Madrid, Spain, 28040
Clara Campal. Hospital Sanchinarro
Madrid, Spain, 28050
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Sponsors and Collaborators
Associació per a la Recerca Oncologica, Spain
Novartis
Pivotal S.L.
Investigators
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Principal Investigator: Joaquim Bellmunt, MD/PhD Associacio Per la Recerca Oncológica (APRO)

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Responsible Party: Associació per a la Recerca Oncologica, Spain
ClinicalTrials.gov Identifier: NCT01784978     History of Changes
Other Study ID Numbers: SUNRISES STUDY (CRAD001LIC34T)
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Keywords provided by Associació per a la Recerca Oncologica, Spain:
cancer
renal
metastatic
clear
cell
Sunitinib
Everolimus
Alternating
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sirolimus
Everolimus
Sunitinib
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action