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Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier:
NCT00854620
First received: February 27, 2009
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

Objectives:

Primary

• Evaluate the safety and toxicity of dose escalating Sorafenib for patients with progressive metastatic renal cell carcinoma.

Secondary:

  • To assess tumor responses produced by Sorafenib
  • To evaluate time to progression produced by Sorafenib
  • To assess overall survival

Methodology:

Open label, multi-center, dose escalation trial

  • Subject maximum dose administered will depend on observed subject tolerability
  • Subject escalation to next dose level will occur only after acceptable tolerance has been demonstrated by Subject

Condition Intervention Phase
Carcinoma, Renal Cell
Kidney Diseases
Kidney (Renal Cell) Cancer
Drug: Sorafenib
Phase 2

Study Type: Interventional
Study Design: 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 at Stanford University

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Evaluate the safety and toxicity of dose escalating Sorafenib for patients with progressive metastatic renal cell carcinoma [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess tumor responses produced by Sorafenib [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • To assess overall survival [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • To evaluate time to progression produced by Sorafenib [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: December 2007
Study Completion Date: January 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sorafenib
    400 mg bid
    Other Name: Nexavar
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1. Histologically or cytologically confirmed metastatic or unresectable renal cell carcinoma (RCC). Patients must have a component of conventional clear cell renal carcinoma.

2. No more than one prior systemic therapy. No prior vascular endothelial growth factor receptor agents.

3. Patients with their primary tumor in place who are appropriate surgical candidates are strongly encouraged (but not required) to undergo nephrectomy 4. Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided the Subject has at least one measurable and/or evaluable lesion(s) that has not been irradiated.

5. All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to Day 1 dosing. Patients must have recovered from surgery and/or radiotherapy toxicity prior to Day 1 dosing.

6. Measureable disease by RECIST criteria 7. Karnofsky performance status >= 70% or ECOG <=2 8. Ability to give written informed consent 9. >= 18 years old 10. Female subjects of childbearing potential must have a negative pregnancy test within 7 days of Day 1 dosing.

11. Sexually active fertile subjects must use an accepted method of contraception during the course of the study and three months thereafter.

12. Subjects with organ and marrow function as follows: ANC >= 1,500/uL Platelet Count >= 100,000/uL AST/ALT <= 2.5 times the upper limit of normal (ULN) Alk. Phosphatase. <= 2.5 x ULN Serum bilirubin <= 1.5 x ULN Amylase/Lipase within normal range Urinalysis <= 1+ protein Pregnancy test for (females Negative of childbearing potential) Serum creatinine <= 1.5 x ULN

ECG, no active ischemia Echocardiogram or MUGA ejection fraction >= 40%

Exclusion Criteria:1. Subjects with ongoing hemoptysis, cerebrovascular accident within 12 months, peripheral vascular disease with claudication on less than 1 block, or history of clinically significant bleeding.

2. Patients with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors and transitional cell carcinoma are NOT eligible.

3. Subjects with deep venous thrombosis or pulmonary embolus within one year of consent. Subjects with 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.

4. Subjects with evidence of current central nervous system (CNS) metastases. All patients must undergo an MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1 dosing.

5. Subjects with 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).

6. Subjects with uncontrolled hypertension (defined as blood pressure of >= 160 mmHg systolic and/or >= 90 mmHg diastolic on medication).

7. Subjects with an ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency). Topical and/or inhaled steroids are allowed.

8. Subject with an uncontrolled psychiatric disorder 9. Subjects with delayed healing of wounds, ulcers, and/or bone fractures are not eligible.

10. Prior malignancy with the following exceptions: adequately treated basal cell or squamous cell skin cancer, as well as any other cancer for which chemotherapy has been completed >5 years ago and from which the patient has been disease-free for > 5 years 11. Pregnant or lactating women. 12. Subjects currently using the herb , St. John's Wort

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854620

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Sandy Srinivas Stanford University
  More Information

No publications provided

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00854620     History of Changes
Other Study ID Numbers: RENAL0009, 96919, SU-02272009-1898
Study First Received: February 27, 2009
Last Updated: July 3, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014