Outcome-related Factors in Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus (ORCHIDEE)

NCT02338570 | Terminated Phase 4

• 1 other identifier: IRFMN-RCC-6691
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 8

Brief Summary

Evaluation of unfavourable outcome-related factors in patients affected by renal cell cancer in treatment with everolimus and previously treated with a Vascular endothelial growth factor (VEGF) inhibitor (i.e. sunitinib, sorafenib,pazopanib, or bevacizumab+interferon)

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• predictive factors identification

  To identify factors predictive of a favourable outcome, in terms of survival free from an unfavourable event, in patients treated with everolimus as second line treatment for metastatic renal cell carcinoma (mRCC). A favourable outcome is being alive and on treatment without both disease progression (according to RECIST 1.1) and HRQoL deterioration (7-point decrease from baseline evaluation on the EQ-5D VAS).

  36 months

Secondary Outcomes (4)

• Progression free survival (PFS) of everolimus as second line treatment

  36 months

• health related quality of life (HRQoL)

  36 months

• drug-related toxicity

  36 months

• compliance

  36 months

Study Arms (1)

Everolimus

OTHER

All patients will receive everolimus 10 mg orally per day. Treatment will continue until progression, unacceptable toxicity, patient refusal or medical decision

Drug: Everolimus

Interventions

Everolimus DRUG

Patients will start study treatment on day 1 and will be treated with daily doses of everolimus (10 mg daily tablets).

Also known as: Afinitor

Everolimus

Eligibility Criteria

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

You may qualify if:

• Male or female, aged 18 years or older, with histologically or cytologically confirmed mRCC (clear cell or not clear cell);
• ECOG-PS 0-1-2;
• With target and/or non-target lesions according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1;
• Following failure of a previous treatment with VEGF-targeted therapy (e.g. sunitinib, sorafenib, pazopanib, or bevacizumab+interferon);
• For whom a decision has been taken to initiate everolimus treatment or patient currently receiving treatment with everolimus by a period of time ≤30 days;
• Willing and able to comply with follow-up and all other protocol requirements and able to commence treatment within 21 days;
• Written informed consent obtained before any screening procedure and according to local guidelines.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from study entry:
• Previous treatment with everolimus or at the date of written informed consent provision receiving everolimus by more than 30 days;
• Symptomatic central nervous system metastases. Patients may be eligible if the central nervous system metastases have been adequately treated (surgery or radiotherapy), and do not require ongoing corticosteroids for control of symptoms and have had no evidence of progression for at least three months;
• 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 past 4 weeks;
• Clinically relevant human immunodeficiency virus, hepatitis B virus, hepatitis C virus infection;
• Non adequate liver function as shown by:
• serum or plasma ALT and AST \>3.0x upper limit of normal (ULN) \>5 if hepatic metastases are present;
• Serum or plasma total bilirubin: \>1.5xULN (excepted for patients with Gilbert's syndrome);
• Non adequate renal function as shown by serum creatinine \>2.5xULN;
• 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;
• Ongoing grade ≥2 cardiac dysrhythmias, atrial fibrillation of any grade or prolongation of the corrected QT interval to \>450 msec for males or \>470 msec for females;
• Pregnancy (negative pregnancy test required for women of child-bearing potential), breast feeding;
• Inadequate contraception. Women must be post-menopausal, surgically sterile, or use a reliable form of contraception. Men must be surgically sterile or use a barrier method of contraception;
• Known allergy or hypersensitivity to everolimus or its excipients.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (8)

Spedali Civili

Brescia, Italy

Location

Ospedale A Perrino

Brindisi, Italy

Location

Istituto Europeo di Oncologia

Milan, Italy

Location

Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale

Napoli, Italy

Location

AOU Maggiore della Carità

Novara, Italy

Location

Casa di Cura La Maddalena

Palermo, Italy

Location

Unicampus Biomedico

Roma, Italy

Location

AOU San Giovanni di Dio e Ruggi D'Aragona

Salerno, Italy

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Everolimus

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)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Giacomo Cartenì

  Azienda Ospedaliera "Antonio Cardarelli", Napoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 14, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 5, 2018

Record last verified: 2016-11

Locations

IT (8)