Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain

Metastatic Cancer Clinical Trial

Official title:

Phase II Study, Multicenter, Open-label, Evaluating Efficacy of Treatment With Sutent® (Sunitinib) in Patients With Previously Untreated or Recurrent Brain Metastases Originating From Renal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814021
• Other study ID #: 07URO02
• Secondary ID: ICREGAUD-07URO02
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2008
• Last updated: November 4, 2014
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: August 2012
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with kidney cancer that has spread to the brain.

Description:

OBJECTIVES:

Primary

• Determine the objective response rate in the brain after 2 courses of sunitnib malate in patients with previously untreated or recurrent brain metastases secondary to renal cancer following radiotherapy or surgery.

Secondary

• Evaluate duration of response.

• Evaluate objective response of non-CNS targets.

• Evaluate time to disease progression.

• Evaluate overall and progression-free survival.

• Evaluate neurological symptoms associated with the tumor.

• Evaluate feasibility and overall tolerance of this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the kidney

• Metastatic disease

• Measurable disease by RECIST criteria

• Presence of previously untreated or recurrent brain metastases following radiotherapy or surgery

• No brain metastasis revealed by hemorrhage

• No single brain metastasis < 2 cm that is accessible by surgery or radiosurgery

PATIENT CHARACTERISTICS:

• WHO performance status 0-2 (unless paresis due to brain metastases)

• ANC > 1,500/mm^3

• Platelet count > 100,000/mm^3

• Hemoglobin > 8 g/dL

• PT or INR < 1.5 times upper limit of normal (ULN)

• AST/ALT < 2.5 times ULN (< 5 times ULN in the case of liver metastases)

• Total bilirubin < 1.5 times ULN

• Serum creatinine < 200 µmol/L

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for up to 30 days following completion of study treatment

• No other cancer except for in situ cervical cancer, curatively treated basal cell carcinoma of the skin, or other curatively treated cancer without evidence of recurrence within the past 5 years

• No uncontrolled hypertension (systolic BP = 160 mm Hg and/or diastolic BP = 90 mm Hg)

• None of the following cardiac conditions within the past 6 months:

• Significant cardiovascular disease

• NYHA class III-IV congestive heart failure

• Myocardial infarction

• Unstable angina

• Severe arrhythmia

• Cerebrovascular accident

• Severe thromboembolism

• No serious neuropsychiatric disease

• No psychological, familial, social, or geographic situations that preclude clinical follow-up

• No patient deprived of liberty by a court or administrative order

• Able to understand French

PRIOR CONCURRENT THERAPY:

• At least 6 months since prior antineoplastic treatment with sunitinib malate

• At least 4 weeks since other prior treatment

• At least 3 weeks since prior hematopoietic growth factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF])

• No concurrent antivitamin K at curative or anticoagulation doses

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• sunitinib malate

Locations

Country	Name	City	State
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate in the brain after 2 courses		From beginning of treatment until 2 courses of treatment	No