Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab

NCT00866320 | Completed Phase 2 Results DMC

• 3 other identifiers: CASE11805P30CA04370305-167
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Sorafenib 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 sorafenib works in treating patients with metastatic kidney cancer that has not responded to sunitinib or bevacizumab.

Conditions

Kidney Cancer

Keywords

clear cell renal cell carcinoma; recurrent renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Tumor Burden Reduction Rate (TBRR)

  The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.

  at 8 weeks (2cycles of treatment)

Secondary Outcomes (3)

• Overall Survival

  followed until progression or death for approximately 3 years

• Time to Progression

  followed to progression for approximately 3 years

• Duration of Overall Response (Tumor Burden Reduction)

  followed for overall response for approximately 3 years

Study Arms (1)

Sorafenib

EXPERIMENTAL

Chemotherapy single agent systemic. Sorafenib given up to 600mg orally every 12 hours for up to 10 months (40 weeks).

Drug: sorafenib tosylate

Interventions

sorafenib tosylate DRUG

Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor targeting both tumor cells and the tumor vasculature. Patients with metastatic RCC meeting eligibility criteria will receive 400 mg BID of sorafenib in a single-arm phase II study. Treatment will be administered on an outpatient basis.

Sorafenib

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma with a component of clear cell histology * Metastatic disease * Disease progression, as defined by RECIST criteria, after prior treatment with sunitinib malate or bevacizumab * Patients must have received ≥ 1 course (4 weeks) of sunitinib malate or ≥ 2 doses of bevacizumab AND have RECIST-defined objective progression during or within 4 months after completing treatment with sunitinib malate or bevacizumab * Measurable disease by RECIST criteria * CNS metastases allowed provided patient has undergone prior surgery and/or radiotherapy AND has no evidence of further CNS disease progression by CT scan or MRI ≥ 2 weeks after treatment of CNS metastases PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 or Karnofsky PS 70-100% * WBC ≥ 3,000/μL * Absolute neutrophil count ≥ 1,500/μL * Platelet count ≥ 75,000/μL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST/ALT ≤ 2.5 times ULN * Creatinine ≤ 2.0 times ULN * Negative pregnancy test * No significant cardiovascular disease, including any of the following: * Congestive heart failure (New York Heart Association class III-IV heart disease) * Active angina pectoris requiring nitrate therapy * Uncontrolled dysrhythmias * Cardiovascular event within the past 6 months (e.g., transient ischemic attack/cerebrovascular accident, myocardial infarction, or vascular surgery) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 2 weeks since prior systemic therapy, radiotherapy, or major surgery and recovered * No prior sorafenib tosylate * No other concurrent investigational agents * No other concurrent anticancer therapy * No concurrent prophylactic growth factors

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sorafenib

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)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Brian Rini
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

rinib2@ccf.org

216-444-9567

Study Officials

• Brian I. Rini, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive 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: March 19, 2009
• First Posted: March 20, 2009
• Study Start: February 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 23, 2014
• Results First Posted: February 1, 2012

Record last verified: 2014-07

Locations

US (2)