Sunitinib Before and After Surgery in Treating Patients With Stage IV Kidney Cancer

NCT00717587 | Unknown Phase 2

• 3 other identifiers: CDR0000600332UPCC-10807PFIZER-807184
• Study Type: interventional
• Target: 20
• 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. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well sunitinib works when given before and after surgery in treating patients with stage IV kidney cancer.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (1)

• Tumor regression as assessed by RECIST criteria

Interventions

motexafin gadolinium DRUG

sunitinib malate DRUG

comparative genomic hybridization GENETIC

gene expression analysis GENETIC

mutation analysis GENETIC

polymorphism analysis GENETIC

immunohistochemistry staining method OTHER

iodine I-124 girentuximab OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

adjuvant therapy PROCEDURE

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of renal cell carcinoma * AJCC stage IV disease * Radiographic evidence of disease for which cytoreductive nephrectomy is deemed to be clinically indicated AND for which preoperative embolization is not deemed necessary by the surgeon * No history or clinical evidence of brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC ≥ 3,000/mm³ * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR serum creatinine clearance ≥ 40 mL/min * Total bilirubin ≤ 1.5 times ULN (\< 3.0 times ULN in the presence of Gilbert's disease) * AST/ALT ≤ 2.5 times ULN (≤ 5.0 times ULN in the presence of liver metastases) * INR ≤ 1.5\* * PTT normal\* * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained in the normal range with medication * No hypertension that cannot be controlled by medications (i.e., diastolic BP ≥ 100 mm Hg despite optimal medical therapy) * No ongoing cardiac dysrhythmias ≥ grade 2 (according to NCI CTCAE v3.0) * No other concurrent malignancies * No concurrent serious illness including, but not limited to, any of the following: * Ongoing or active infection requiring parenteral antibiotics * Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina) * New York Heart Association class II-IV congestive heart failure * Serious cardiac arrhythmia requiring medication * Peripheral vascular disease ≥ grade 2 within the past year * Psychiatric illness/social situation that would limit compliance with study requirements NOTE: \*Patients who are taking warfarin must have documentation of an INR ≤ 1.5 and PTT normal prior to the initiation of anticoagulation to rule out a baseline coagulopathy PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior radiotherapy and recovered * Prior radiotherapy to a symptomatic site of metastatic disease is allowed * No prior systemic therapy * No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort) * No other concurrent investigational agents

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

motexafin gadolinium; Sunitinib; Comparative Genomic Hybridization; Gene Expression Profiling; Amplified Fragment Length Polymorphism Analysis; Immunohistochemistry; Chemotherapy, Adjuvant; Neoadjuvant Therapy

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; Cytogenetic Analysis; Genetic Techniques; Investigative Techniques; Molecular Diagnostic Techniques; Nucleic Acid Hybridization; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Keith T. Flaherty, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 17, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2010
• Last Updated: January 10, 2014

Record last verified: 2009-01

Locations

US (1)