Sunitinib Before or After Surgery in Treating Patients With Metastatic Kidney Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sunitinib 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. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective when given before or after surgery in treating kidney cancer.

PURPOSE: This randomized phase II trial is studying the side effects of sunitinib and to compare how well it works when given before or after surgery in treating patients with metastatic kidney cancer.

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

Details

• Lead Sponsor: Gruppo Italiano Carcinoma Renale
• Treatments: Sunitinib

Criteria

DISEASE CHARACTERISTICS:

• Proven metastatic renal cell carcinoma

• Measurable disease (according to RECIST criteria)

• Eligible for cytoreductive nephrectomy

• Primary tumor is considered amenable to surgical extirpation by the attending surgeon

• Thrombosis of the inferior vena cava below the epathic veins allowed

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Adequate hematology and coagulation

• Amylase and lipase normal

• Adequate hepatic, renal, and cardiac function

• Not pregnant

• Negative pregnancy test

• No uncontrolled hypertension and/or clinically significant cardiovascular events or disease within the past 12 months

• No other cancer within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

• No prior early nephrectomy due to clinical condition

• No prior systemic therapy for renal cell carcinoma (e.g., chemotherapy, hormonal therapy, interferon, interleukin-2, lymphocyte-activated killer cells, or other biological response modifiers)

• More than 12 days since prior potent CYP3A4 inducers, including any of the following:

• Rifampin

• Rifabutin

• Carbamazepine

• Phenobarbital

• Phenytoin

• St. John's wort

• Efavirenz

• Tipranavir

• More than 7 days since prior potent CYP3A4 inhibitors, including any of the following:

• Ketoconazole

• Itraconazole

• Clarithromycin

• Erythromycin

• Diltiazem

• Verapamil

• Delavirdine

• Indinavir

• Saquinavir

• Ritonavir

• Atazanavir

• Nelfinavir

• No other concurrent approved or investigational anticancer treatment, including chemotherapy, biological response modifiers, hormonal therapy, or immunotherapy

• No concurrent participation in any other treatment clinical trial

• No concurrent palliative radiotherapy or surgery

• No concurrent drugs with proarrhythmic potential, including any of the following:

• Terfenadine

• Quinidine

• Procainamide

• Disopyramide

• Sotalol

• Probucol

• Bepridil

• Haloperidol

• Risperidone

• Indapamide

• Flecainide

• Concurrent bisphosphonate therapy for metastatic bone disease allowed provided therapy was initiated at least 4 weeks prior to the first dose of study drug