Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

NCT ID: NCT00459875

Last Updated: 2015-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-11-30

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 locally recurrent or metastatic kidney cancer.

Detailed 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.

Conditions

Kidney Cancer

Study Design

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

Study Groups

Sunitinib

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.

Group Type: EXPERIMENTAL

sunitinib malate

Intervention Type: DRUG

Interventions

sunitinib malate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn Kroog, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Robert J. Motzer, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

References

Molina AM, Feldman DR, Ginsberg MS, Kroog G, Tickoo SK, Jia X, Georges M, Patil S, Baum MS, Reuter VE, Motzer RJ. Phase II trial of sunitinib in patients with metastatic non-clear cell renal cell carcinoma. Invest New Drugs. 2012 Feb;30(1):335-40. doi: 10.1007/s10637-010-9491-6. Epub 2010 Aug 14.

Reference Type: RESULT

PMID: 20711632 (View on PubMed)

Other Identifiers

P30CA008748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSKCC-07019

Identifier Type: -

Identifier Source: secondary_id

07-019

Identifier Type: -

Identifier Source: org_study_id