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Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00445042
First Posted: March 8, 2007
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bayer
Amgen
Information provided by (Responsible Party):
The Methodist Hospital System
  Purpose
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.

Condition Intervention Phase
Carcinoma, Renal Cell Drug: Sorafenib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • Tumor progression rate by RECIST criteria [ Time Frame: restaging every 8 weeks ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: restaging every 8 weeks ]
  • Time to progression and overall survival [ Time Frame: restaging every 8 weeks ]

Enrollment: 71
Study Start Date: November 2005
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Intrapatient dose escalation study of sorafenib
Drug: Sorafenib
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.
Other Name: Nexavar

Detailed Description:

Because tumors may have multiple mechanisms to induce angiogenesis, blockade with sorafenib may demonstrate efficacy. Doses of sorafenib (400 mg b.i.d.) as a single agent is with minimal toxicity, presents an opportunity to explore a more intensive drug administration. This study will allow individual patient titration (e,g,, intrapatient dose escalation) as per protocol.

This provides the basis for the dose escalation development of sorafenib. The study is designed to evaluate the ability for patients to dose escalate. Secondary endpoints include; response, time to progression, and overall survival in patients with MRCC. Tissue correlation to evaluate the impact of expression of receptor on clinical outcome will be retrospectively performed. Laboratory correlation of plasma VEGF levels will be correlated and evaluated to clinical outcome.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445042


Locations
United States, Texas
Methodist Hospital - Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Bayer
Amgen
Investigators
Principal Investigator: Robert J Amato, DO Baylor College of Medicine - Methodist Hospital
  More Information

Additional Information:
Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT00445042     History of Changes
Other Study ID Numbers: PAC IRB#03-0194-05
Sorafenib-RCC-01
First Submitted: March 7, 2007
First Posted: March 8, 2007
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Methodist Hospital System:
Metastatic Renal Cell Carcinoma
Metastatic RCC
Kidney Cancer
M3thodist

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs