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

NCT ID: NCT00814021

Last Updated: 2014-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-03-31

Brief 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.

Detailed 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.

Conditions

Kidney Cancer; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sunitinib,

Group Type: EXPERIMENTAL

sunitinib malate

Intervention Type: DRUG

Interventions

sunitinib malate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Chevreau-Dalbianco, MD

Role: STUDY_CHAIR

Institut Claudius Regaud

Locations

Institut Claudius Regaud

Toulouse, , France

Countries

France

Other Identifiers

ICREGAUD-07URO02

Identifier Type: -

Identifier Source: secondary_id

ICREGAUD-Metastases Cerebrales

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0821

Identifier Type: -

Identifier Source: secondary_id

PFIZER-ICREGAUD-07URO02

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2008-000948-13

Identifier Type: -

Identifier Source: secondary_id

07URO02

Identifier Type: -

Identifier Source: org_study_id