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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer, Metastatic Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate in the brain after 2 courses

Safety Issue:

No

Principal Investigator

Christine Chevreau-Dalbianco, MD

Investigator Affiliation:

Institut Claudius Regaud

Authority:

Unspecified

Study ID:

CDR0000626806

NCT ID:

NCT00814021

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Metastatic Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • tumors metastatic to brain
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

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