Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

This study has been completed.
Sponsor:
Collaborators:
Bayer
Onyx Pharmaceuticals
Information provided by:
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00445042
First received: March 7, 2007
Last updated: January 30, 2009
Last verified: January 2009
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
  • Time to progression and overall survival [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445042

Locations
United States, Texas
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Bayer
Onyx Pharmaceuticals
Investigators
Principal Investigator: Robert J Amato, DO The Methodist Hospital Research Institute
  More Information

No publications provided

Responsible Party: Robert J. Amato, DO, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00445042     History of Changes
Other Study ID Numbers: Sorafenib-RCC-01, 03-0194-05
Study First Received: March 7, 2007
Last Updated: January 30, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014