Assessing Everolimus in Fist Line Treatment on Patients With Metastatic Kidney Cancer

NCT01888042 | Terminated Phase 2

• 2 other identifiers: 2011-00979-142011/1733
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

It is a an open label, multicentric, phase II study assessing the efficacy of everolimus (given per os) as a first line treatment in kidney cancer of bad prognosis. 92 patients will be included (anticipated). The treatment by everolimus will continue until progression, significant toxicity or withdraw of consent

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  From inclusion to progression, significant toxicity or death wichever come first up to 56 months

Secondary Outcomes (3)

• Response rate

  From inclusion to progression, significant toxicity or death whichever come first up to 56 months

• Toxicity of Everolimus

  From inclusion to progression, significant toxicity or death whichever come first up to 56 months

• Progression Free Survival (PFS)

  From inclusion to progression, significant toxicity or death whichever come first up to 56 months

Study Arms (1)

Everolimus

EXPERIMENTAL

Everolimus will be administered per os every day at the same hour immediately after a meal with a glass of water 10 mg (1 tablet of 10 mg)

Drug: Everolimus

Interventions

Everolimus DRUG

10 mg (1 tablet of 10 mg)

Everolimus

Eligibility Criteria

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

You may qualify if:

• Metastatic kidney cancer, regardless of histology (except Bellini carcinomas), with measurable or evaluable disease
• Age \>= 18 years
• With Karnofsky ≥ 60
• Without prior treatment for metastatic cancer (chemotherapy, targeted therapy, or mTOR inhibitor)
• Bad prognosis, defined as follows: at least three of the following six criteria of poor prognosis:
• Karnofsky \<80
• LDH\> 1.5 ULN
• hemoglobin \<LLN
• corrected calcium\> 2.5 mmol / l (10 mg / dl)
• Time frame between initial diagnostic and treatment \<1 year
• More than one metastatic site
• medullary function: neutrophils ≥ 1.5 x 109 / L, Platelets ≥ 100 x 109 / L, Hb\> 8g/dL
• Hepatic function: bilirubin: ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN in the absence of hepatic metastasis ≤ 5x ULN if hepatic metastasis documented
• Renal function: creatinine \<1.5 x ULN
• Life expectancy\> 3 months,

You may not qualify if:

• Previous treatment with chemotherapy, targeted therapy, or mTOR inhibitor
• Previous radiotherapy in the last 2 weeks
• Patients with brain metastases untreated or uncontrolled by prior treatment. The non-progression of the metastases must be proved by comparing two brain scans separated by a minimum interval of 6 weeks.
• Active bleeding
• Patient with positive serology HBs (Ag HBs (+) and AC anti-HBc (+)
• Hypersensitivity to everolimus, sirolimus, to other rapamycin derivatives or to any of the excipients
• Severe or uncontrolled medical pathology:
• unstable angina, symptomatic heart failure, myocardial infarction ≤ 6 months before randomization, severe rhythm disorder,
• Uncontrolled diabetes with glycaemia\> 1.5X ULN.
• Active or uncontrolled infection.
• cirrhosis or chronic active hepatitis,
• severe alteration in lung function (\> 50% decrease in FEV or vital capacity)
• Other cancer within the past 3 years, with the exception of basal cell carcinoma and carcinoma in situ of the cervix
• Pregnant or lactating woman, and adults refusing an effective contraceptive method
• Participation in another clinical trial with an investigational drug

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; 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

• Bernard ESCUDIER

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 27, 2013
• Study Start: July 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

FR (1)