Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in treating patients with metastatic or unresectable kidney cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborators: Bayer; National Cancer Institute (NCI)
• Treatments: Niacinamide; Sorafenib

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed renal cell carcinoma (RCC)

• Must have a component of conventional clear cell RCC

• Predominant clear cell component ≥ 75%

• Patients with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors, or transitional cell carcinoma are not eligible

• Metastatic or unresectable disease

• Measurable or nonmeasurable disease

• Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan or MRI

• Nonmeasurable disease includes any of the following:

• Small lesions with longest diameter < 20 mm by conventional techniques or < 10 mm by spiral CT scan

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Lymphangitis cutis/pulmonitis

• Abdominal masses that are not confirmed and followed by imaging techniques

• Cystic lesions

• Irradiated lesions, unless progression is documented after radiotherapy

• Paraffin RCC tissue blocks or unstained slides must be obtained for future chemistry staining of VEGF

• No evidence of CNS metastases

• No imaging (MRI or CT scan of the brain) abnormality indicative of CNS metastases within the past 42 days

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception (hormonal and/or barrier method) during and for 3 months after completion of study treatment

• Granulocyte count ≥ 1,500/µL

• Platelet count ≥ 100,000/µL

• AST/ALT ≤ 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN

• Serum bilirubin ≤ 1.5 times ULN

• Protein ≤ 1+ by urinalysis

• Creatinine ≤ 1.5 times ULN

• No ongoing hemoptysis

• No cerebrovascular accident within the past 12 months

• No peripheral vascular disease with claudication while walking less than 1 block

• No history of clinically significant bleeding

• No deep venous thrombosis or pulmonary embolus within the past year

• No significant cardiovascular disease, defined as NYHA class II-IV congestive heart failure, angina pectoris requiring nitrate therapy, or myocardial infarction within the past 6 months

• No uncontrolled hypertension, defined as systolic BP > 160 mm Hg and/or diastolic BP > 90 mm Hg while on medication

• No preexisting thyroid abnormality whose thyroid function cannot be maintained in the normal range by medication

• No uncontrolled psychiatric disorder

• No delayed healing of wounds, ulcers, and/or bone fractures

• No currently active second malignancy except nonmelanoma skin cancer

• Patients are not considered to have a 'currently active' malignancy if they have completed anticancer therapy and are considered by their physician to be at less than 30% risk of relapse

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior major surgery and/or radiotherapy and recovered

• No more than one prior systemic therapy for RCC

• No prior vascular endothelial growth factor receptor agents

• Prior palliative radiotherapy for metastatic lesion(s) allowed provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated

• More than 4 weeks since prior and no other concurrent anticancer therapy

• Concurrent continuation of bisphosphonates allowed for bone metastases prophylaxis

• No concurrent systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency)

• Topical and/or inhaled steroids allowed

• No concurrent full-dose oral or parenteral anticoagulation

• Low-dose warfarin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin allowed

• No concurrent Hypericum perforatum (St. John's wort)

• No concurrent ketoconazole, itraconazole, ritonavir, rifampin, or products containing grapefruit juice

• No concurrent hormonal therapy or chemotherapy

• Concurrent hormones administered for non-disease related conditions (e.g., insulin for diabetes) allowed