Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	MSKCC-04001 PFIZER-A6181006, NCT00082849

Objectives

Primary

1. Determine the antitumor efficacy of SU011248 in patients with cytokine-refractory metastatic renal cell cancer.

Secondary

1. Determine duration of tumor control in patients treated with this drug.
2. Determine overall survival of patients treated with this drug.
3. Determine the safety and tolerability of this drug in these patients.
4. Correlate plasma concentration with efficacy and safety parameters of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed renal cell cancer
  • Metastatic disease
  • Clear cell histology



• Unidimensionally measurable disease
  • At least 1 malignant tumor mass that is at least 20 mm by conventional radiographic techniques or MRI OR at least 10 mm by spiral CT scan
  • The following are not considered measurable:
    • Bone lesions
    • Ascites
    • Peritoneal carcinomatosis or miliary lesions
    • Pleural or pericardial effusions
    • Lymphangitis of the skin or lung
    • Cystic lesions
    • Irradiated lesions



• Failed 1, and only 1, prior cytokine therapy with interleukin-2 (IL-2), interferon alfa (IFN-A)*, or a combination of IL-2 and IFN-A*
  • Radiographic evidence of disease progression during or within 9 months after completion of therapy

   [Note: *Prior pegylated interferon alfa may be used instead of IFN-A]




• Underwent prior nephrectomy



• No history of or known brain metastases, spinal cord compression, or carcinomatous meningitis
  • No new evidence of brain or leptomeningeal disease on screening CT scan or MRI



• No papillary, collecting duct, or chromophobe type renal cell carcinoma

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• Recovered from prior cytokine therapy
• No other prior cytokine-based therapy
• No concurrent biological response modifiers
• No concurrent immunotherapy

Chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• No concurrent radiotherapy to the only site of measurable disease
• Concurrent palliative radiotherapy allowed

Surgery

• See Disease Characteristics
• At least 4 weeks since prior surgery and recovered
• More than 12 months since prior coronary/peripheral artery bypass graft
• No concurrent surgery to the only site of measurable disease

Other

• At least 4 weeks since prior systemic therapy
• No other prior systemic therapy (except IFN-A, IL-2, or a combination of IFN-A and IL-2)
• No concurrent participation in another clinical trial
• No other concurrent approved or investigational anticancer treatment
• No other concurrent investigational drugs

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• No ongoing hemorrhage of grade 3

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to underlying malignancy)
• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN
• Calcium ≤ 12.0 mg/dL

Cardiovascular

• LVEF ≥ lower limit of normal by MUGA
• No ongoing cardiac dysrhythmias ≥ grade 2
• No atrial fibrillation of any grade
• No prolongation of the QTc interval to > 450 msec for males OR > 470 msec for females
• No hypertension that cannot be controlled with medications
• None of the following within the past 12 months:
  • Myocardial infarction
  • Severe/unstable angina
  • Symptomatic congestive heart failure
  • Cerebrovascular accident or transient ischemic attack
  • Pulmonary embolism
  • Deep vein thrombosis

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study participation
• Amylase and lipase ≤ 1.5 times ULN
• Adrenocorticotrophic hormone stimulation test normal
• HIV negative
• No AIDS-related illness
• No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

Expected Enrollment

A total of 100 patients will be accrued for this study.

Outline

This is an open-label, multicenter study.

Patients receive oral SU011248 once daily on weeks 1-4. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 2 months thereafter.

Motzer RJ, Michaelson MD, Redman BG, et al.: Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol 24 (1): 16-24, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Robert Motzer, MD, Principal investigator		Ph: 646-422-4312; 800-525-2225

Registry Information
Official Title		A Pivotal Study of SU11248 in the Treatment of Patients with Cytokine-Refractory Metastatic Renal Cell Carcinoma
Registered in ClinicalTrials.gov		NCT00082849
Date Submitted to PDQ		2004-03-03
Information Last Verified		2005-04-06
NCI Grant/Contract Number		CA08748

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