Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

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Stanford University

Status and phase

Completed
Phase 2

Conditions

Carcinoma, Renal Cell
Kidney Cancer
Kidney Disease

Treatments

Drug: Sorafenib

Study type

Interventional

Funder types

Other

Identifiers

NCT00854620
SU-02272009-1898 (Other Identifier)
96919 (Other Identifier)
RENAL0009 (Other Identifier)
IRB-04988

Details and patient eligibility

About

Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib

Full description

Sorafenib to be administered as 28-day cycles. Sorafenib dose escalation by cycle is: Cycle 1: 400 mg BID Cycle 2: 600 mg BID Cycle 3+: 800 mg BID Within subject dose escalation and maximum dose is dependent on observed tolerability. Dose escalation only occurs after acceptable tolerability is demonstrated by subject.

Enrollment

9 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Histologically- or cytologically-confirmed metastatic or unresectable renal cell carcinoma (RCC).
  2. must have a component of conventional clear cell renal carcinoma.
  3. No more than one prior systemic therapy.
  4. No prior vascular endothelial growth factor receptor agents.
  5. 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.
  6. 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.
  7. Measureable disease by RECIST criteria
  8. Karnofsky performance status at least 70% or ECOG not more than 2
  9. Ability to give written informed consent
  10. At least 18 years old
  11. Negative pregnancy test within 7 days of Day 1 dosing (female subjects of childbearing potential)
  12. Sexually active fertile subjects must agree to use an accepted method of contraception during the course of the study for 3 months thereafter.
  13. ANC at least 1,500/uL
  14. Platelet count at least 100,000/uL
  15. AST/ALT not more than 2.5 times the upper limit of normal (ULN)
  16. Alkaline phosphatase not more than 2.5 x ULN
  17. Serum bilirubin not more than 1.5 x ULN
  18. Amylase/Lipase within normal range
  19. Urinalysis not more than 1+ protein
  20. Serum creatinine not more than 1.5 x ULN
  21. No active ischemia by ECG
  22. Echocardiogram or MUGA ejection fraction at least 40%

Exclusion criteria

  1. Ongoing hemoptysis
  2. Cerebrovascular accident within 12 months
  3. Peripheral vascular disease with claudication on less than 1 block
  4. History of clinically significant bleeding
  5. Malignancy with true papillary/sarcomatoid features without any clear cell component
  6. Chromophobe
  7. Oncocytoma
  8. Collecting duct tumors
  9. Transitional cell carcinoma
  10. Deep venous thrombosis or pulmonary embolus within one year of consent
  11. 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
  12. Subjects with evidence of current central nervous system (CNS) metastases
  13. MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1 dosing
  14. Significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV)
  15. Angina pectoris requiring nitrate therapy
  16. Myocardial infarction within the last 6 months
  17. Uncontrolled hypertension (defined as blood pressure at least 160 mmHg systolic or at least 90 mmHg diastolic on medication)
  18. Ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency). Topical and/or inhaled steroids are allowed.
  19. Uncontrolled psychiatric disorder
  20. Delayed healing of wounds, ulcers, and/or bone fractures
  21. Prior malignancy (EXCEPTIONS: adequately-treated basal cell or squamous cell skin cancer or any other cancer for which chemotherapy has been completed > 5 years ago and from which the patient has been disease-free for > 5 years)
  22. Pregnant
  23. Currently lactating
  24. Currently using St John's Wort (an herb)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Sorafenib
Experimental group
Description:
Cycle 1: 400 mg BID sorafenib Cycle 2: 600 mg BID sorafenib Cycle 3+: 800 mg BID sorafenib
Treatment:
Drug: Sorafenib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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