Sunitinib Before and After Surgery in Treating Patients With Stage IV 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.

PURPOSE: This phase II trial is studying how well sunitinib works when given before and after surgery in treating patients with stage IV kidney cancer.

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

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Collaborator: National Cancer Institute (NCI)
• Treatments: Motexafin gadolinium; Sunitinib

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of renal cell carcinoma

• AJCC stage IV disease

• Radiographic evidence of disease for which cytoreductive nephrectomy is deemed to be clinically indicated AND for which preoperative embolization is not deemed necessary by the surgeon

• No history or clinical evidence of brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• WBC ≥ 3,000/mm³

• Absolute granulocyte count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR serum creatinine clearance ≥ 40 mL/min

• Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN in the presence of Gilbert's disease)

• AST/ALT ≤ 2.5 times ULN (≤ 5.0 times ULN in the presence of liver metastases)

• INR ≤ 1.5*

• PTT normal*

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained in the normal range with medication

• No hypertension that cannot be controlled by medications (i.e., diastolic BP ≥ 100 mm Hg despite optimal medical therapy)

• No ongoing cardiac dysrhythmias ≥ grade 2 (according to NCI CTCAE v3.0)

• No other concurrent malignancies

• No concurrent serious illness including, but not limited to, any of the following:

• Ongoing or active infection requiring parenteral antibiotics

• Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina)

• New York Heart Association class II-IV congestive heart failure

• Serious cardiac arrhythmia requiring medication

• Peripheral vascular disease ≥ grade 2 within the past year

• Psychiatric illness/social situation that would limit compliance with study requirements NOTE: *Patients who are taking warfarin must have documentation of an INR ≤ 1.5 and PTT normal prior to the initiation of anticoagulation to rule out a baseline coagulopathy

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since prior radiotherapy and recovered

• Prior radiotherapy to a symptomatic site of metastatic disease is allowed

• No prior systemic therapy

• No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)

• No other concurrent investigational agents