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Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

Phase II Study of Sunitinib in Patients With Metastatic Papillary Renal Cell Carcinoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00459875
Enrollment
24
Registered
2007-04-13
Start date
2007-03-31
Completion date
2010-11-30
Last updated
2015-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer, stage IV renal cell cancer

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.

Interventions

DRUGsunitinib malate

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Overall Objective Response Rate as Measured by RECIST2 years

Countries

United States

Participant flow

Participants by arm

ArmCount
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. sunitinib malate
24
Total24

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event2
Overall StudyIneligible participant1

Baseline characteristics

CharacteristicSunitinib
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
8 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
18 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
21 / 23
serious
Total, serious adverse events
11 / 23

Outcome results

Primary

Overall Objective Response Rate as Measured by RECIST

Time frame: 2 years

ArmMeasureGroupValue (NUMBER)
SunitinibOverall Objective Response Rate as Measured by RECISTStable Disease (SD)16 participants
SunitinibOverall Objective Response Rate as Measured by RECISTProgression of Disease (POD)6 participants
SunitinibOverall Objective Response Rate as Measured by RECISTPartial Response (PR)1 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026