Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

NCT00445042 | Completed Phase 2

• 2 other identifiers: PAC IRB#03-0194-05Sorafenib-RCC-01
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and toxicity levels of Dose Escalated Sorafenib in the treatment of patients with renal cancer.

Conditions

Carcinoma, Renal Cell

Keywords

Metastatic Renal Cell Carcinoma; Metastatic RCC; Kidney Cancer; M3thodist

Outcome Measures

Primary Outcomes (1)

• Tumor progression rate by RECIST criteria

  restaging every 8 weeks

Secondary Outcomes (2)

• Overall response rate

  restaging every 8 weeks

• Time to progression and overall survival

  restaging every 8 weeks

Study Arms (1)

A

EXPERIMENTAL

Intrapatient dose escalation study of sorafenib

Drug: Sorafenib

Interventions

Sorafenib DRUG

The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the protocol, providing no dose limiting toxicity (Grade 3 or 4) is observed.

Also known as: Nexavar

A

Eligibility Criteria

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

You may qualify if:

• Histologically or cytological confirmed metastatic or unresectable clear cell renal cell carcinoma.
• No more than one prior systemic therapy. No prior vascular endothelial growth factor receptor agents.
• Patients with primary tumor in place are strongly encouraged to undergo nephrectomy prior to initiation of study agent.
• Prior palliative radiotherapy to metastatic lesion(s) is permitted.
• All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to registration.
• Patients must have metastatic or unresectable disease.
• Paraffin RCC tissue blocks or unstained slides must be available.
• Karnofsky performance status \> 70 % .
• Not pregnant
• Age \> 18
• Must meet required initial laboratory values

You may not qualify if:

• No ongoing hemoptysis, or cerebrovascular accident within 12 months, or peripheral vascular disease with claudication on less than 1 block, or history of clinically significant bleeding.
• No deep vein thrombosis or pulmonary embolus within one year of study enrollment and no ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed.
• No evidence of current central nervous system (CNS) metastasis. All patients must undergo an MRI or CT scan of the brain (with contrast, if possible) within 42 days prior to registration. Any imaging abnormality indicative of CNS metastases will exclude the patient from the study.
• No significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV) angina pectoris requiring nitrate therapy, or recent myocardial infarction (within the last 6 months).
• No patients with uncontrolled hypertension (defined as blood pressure of \>160 mmHg systolic and/or \> 90 mmHg diastolic on medication).
• Any ongoing requirement for systemic corticosteroid therapy is not permitted. Topical and/or inhaled steroids are allowed.
• No pre-existing thyroid abnormality whose thyroid function cannot be maintained in the normal range by medication are ineligible.
• No uncontrolled psychiatric disorder.
• Patients with delayed healing of wounds, ulcers and/or bone fractures are not eligible
• Patients with a 'currently active' second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a 'currently active' malignancy if they have completed anti-cancer therapy and are considered by their physician to be a less than 30% risk of relapse.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Bayer: collaborator
• Amgen: collaborator

Study Sites (1)

Methodist Hospital - Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

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

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

Study Officials

• Robert J Amato, DO

  Baylor College of Medicine - Methodist Hospital

  PRINCIPAL INVESTIGATOR

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 7, 2007
• First Posted: March 8, 2007
• Study Start: November 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)