Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Kidney Cancer

Treatments: Drug: sunitinib malate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00459875

P30CA008748 (U.S. NIH Grant/Contract)

07-019

MSKCC-07019

Details and patient eligibility

About

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 locally recurrent or metastatic kidney cancer.

Full description

OBJECTIVES:

Primary

• Determine the efficacy of sunitinib malate in patients with locally recurrent or metastatic papillary renal cell carcinoma.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 28 days and every 2 months thereafter.

Enrollment: 24 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced renal cell carcinoma of papillary or other non-clear cell histology

  • Metastatic or locally recurrent disease

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

  • The following are considered nonmeasurable disease:

    • Bone lesions
    • Ascites
    • Peritoneal carcinomatosis or miliary lesions
    • Pleural or pericardial effusions
    • Lymphangitis of the skin or lung
    • Cystic lesions
    • Irradiated lesions

• Patients with primary tumor in place who are eligible for surgery must have undergone prior partial or radical nephrectomy

• No history of or known brain metastases, spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9.0 g/dL

• Calcium ≤ 12.0 mg/dL

• Creatinine ≤ 1.5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

• AST and ALT ≤ 2.5 times ULN (5 times ULN if liver function abnormalities are due to underlying malignancy)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No hemorrhage ≥ grade 3 within the past 4 weeks

• No diagnosis of any second malignancy within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer

• None of the following within the past 6 months:

  • Myocardial infarction
  • Severe or unstable angina
  • Coronary or peripheral artery bypass graft
  • Symptomatic congestive heart failure
  • Cerebrovascular accident or transient ischemic attack
  • Pulmonary embolism

• No ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade

• No prolongation of the QTc interval to > 450 msec (males) or > 470 msec (females)

• No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite optimal medical therapy)

• No pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication

• No known HIV or AIDS-related illness

• No other active infection

• No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior sunitinib malate

• Prior or concurrent bisphosphonates allowed

• More than 4 weeks since prior radiotherapy and recovered

• Prior palliative radiotherapy to metastatic lesions allowed provided there is ≥ 1 measurable lesion that has not been irradiated

• More than 4 weeks since prior major surgery and recovered

• No concurrent therapeutic doses of warfarin

  • Low-dose warfarin ≤ 2 mg daily for thromboprophylaxis allowed
  • Concurrent low molecular weight heparin for full anticoagulation allowed

• No other concurrent approved or investigational anticancer treatment, including chemotherapy, biological response modifiers, hormonal therapy, or immunotherapy

• No other concurrent investigational drugs

• No concurrent treatment on another clinical trial

  • Concurrent participation on supportive care trials or nontreatment trials (e.g., quality of life trials) allowed

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Sunitinib

Experimental group

Description:

The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.

Treatment:

Drug: sunitinib malate