Sorafenib in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

NCT00727532 | Terminated Results DMC

• 3 other identifiers: NU 07U1P30CA060553NU-IRB-STU00003123
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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. Giving sorafenib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying how well sorafenib works in treating patients with locally advanced or metastatic kidney cancer.

Conditions

Hereditary Clear Cell Renal Cell Carcinoma; Kidney Cancer

Keywords

clear cell renal cell carcinoma; hereditary clear cell renal cell carcinoma; recurrent renal cell cancer; stage I renal cell cancer; stage II renal cell cancer; stage III renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Percentage Change in Difference in Apparent Diffusion Coefficient Between Baseline and Week 5

  Mean Difference in Apparent Diffusion Coefficient \[Time Frame: Baseline and Week 5\] To assess whether changes in the apparent diffusion coefficient (ADC) during neoadjuvant sorafenib treatment are detectable in locally advanced or metastatic kidney cancer. The ADC value will be calculated at baseline (within 28 days of initiating sorafenib) and Week 5, and the mean difference will be calculated. The percent change between this mean difference is reported. Week 5 ADC value minus baseline ADC value/divided by baseline ADC value was calculated for each participant. Apparent diffusion coefficient (ADC), obtained by measuring diffusion values at magnetic resonance imaging (MRI), is a measure of water mobility. Lower values correspond to tumor and higher values are consistent with cysts. With sorafenib therapy, the amount of free water may increase in a lesion due to necrosis, and as a result the ADC may increase in value.

  Baseline and week 5

• Change in Tumor Size From Baseline to Approximately 29-34 Days After Completion of Neoadjuvant Sorafenib Treatment

  Tumors were measured at baseline and approximately 29-34 days after completion of neoadjuvant treatment with sorafenib (just prior to surgery). Tumors were assessed by RECIST response criteria.

  Just prior to study week 5

Study Arms (1)

Sorafenib

EXPERIMENTAL

Eligible patients undergo pre-treatment DW-MRI of the abdomen and pelvis. Patient then receive Sorafenib 400mg orally twice daily on days 1-28. Following completion of 28 days of sorafenib, patients obtain a second DW-MRI.

Drug: Sorafenib

Interventions

Sorafenib DRUG

400mg by mouth twice daily for 28 consecutive days

Also known as: Nexavar

Sorafenib

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed clear cell renal cell carcinoma, meeting 1 of the following criteria: * Localized disease, as evidenced by intact, bulky, and primary renal lesions (T1 \> 3 cm, any T2, T3, or T4) appropriate for nephrectomy * Limited metastatic disease, as evidenced by any renal primary (T1 \> 3 cm, any T2, T3, or T4) appropriate for cytoreductive nephrectomy * Isolated abdominal/pelvic recurrence with limited metastatic burden (minimum size \> 2 cm) appropriate for metastasectomy * No known brain metastasis * Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group performance status 0-1 * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alanine aminotransferase and Aspartate aminotransferase ≤ 2.5 times ULN (≤ 5 times ULN with liver involvement) * Creatinine ≤ 1.5 times ULN * Estimated glomerular filtration rate \> 30 mL/min (for patients receiving Gd-enhanced MRI) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception prior to, during (men and women), and for at least 3 months after (men) completion of study therapy * Adequate cardiac and pulmonary status for operative therapy * No active clinically serious infection \> CTCAE grade 2 * No known HIV, hepatitis B, or hepatitis C infections * No serious non-healing wound, ulcer, or bone fracture * No significant traumatic injury within the past 4 weeks * No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks * No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks * No history of an uncontrolled bleeding disorder including, but not limited to, any of the following: * Bleeding diathesis * Coagulopathy * No cardiac disease or condition including, but not limited to, any of the following: * New York Heart Association class II-IV congestive heart failure * Unstable angina (anginal symptoms at rest) * New onset angina beginning within the last 3 months * Myocardial infarction within the past 6 months * Cardiac ventricular arrhythmias requiring antiarrhythmic therapy * No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 100 mm Hg) despite optimal medical management * No thrombolic or embolic events within the past 6 months (e.g., cerebrovascular accident including transient ischemic attacks) * No condition that impairs the ability to swallow whole pills * No malabsorption problem * No contraindication to MRI, including, but not limited to, any of the following: * Ferromagnetic implants * Dental work * Pacemakers * Metallic implants * Severe claustrophobia which precludes closed MRI testing * No known or suspected allergy to sorafenib tosylate * No contraindication or allergy to gadolinium (e.g., end stage renal disease requiring hemodialysis) * No intercurrent illness or situation which, in the judgment of the investigator, would affect assessments of clinical status and study endpoints significantly PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior major surgery or open biopsy * No prior therapy with tyrosine kinase or vascular endothelial growth factor inhibitors (e.g., sunitinib malate, sorafenib, or bevacizumab) * No concurrent Hypericum perforatum (St. John's wort) or rifampin * No concurrent use of illicit drugs or other substances that may, in the opinion of the investigator, have a reasonable chance of contributing to toxicity or interfering with study results

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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, 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

Limitations and Caveats

The trial did not reach the original goal of 10 subjects. Only 9 out of 10 patients had been enrolled, with no accrual for a period of more than 1 year. Therefore it was administratively closed by the Data Monitoring Committee.

Results Point of Contact

• Title: Results Entry Administrator
• Organization: Northwestern University

croqualityassurance@northwestern.edu

312-695-1301

Study Officials

• Timothy M. Kuzel, MD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2008
• First Posted: August 4, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: September 1, 2013
• Last Updated: May 3, 2019
• Results First Posted: May 3, 2019

Record last verified: 2018-10

Locations

US (1)