Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

NCT00459875 | Completed Phase 2 Results

• 3 other identifiers: 07-019P30CA008748MSKCC-07019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Overall Objective Response Rate as Measured by RECIST

  2 years

Study Arms (1)

Sunitinib

EXPERIMENTAL

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.

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

Sunitinib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 20711632 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Robert Motzer
• Organization: Memorial Sloan Kettering Cancer Center

motzerr@mskcc.org

646-422-4312

Study Officials

• Glenn Kroog, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Robert J. Motzer, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2007
• First Posted: April 13, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 26, 2015
• Results First Posted: November 26, 2015

Record last verified: 2015-10

Locations

US (1)