N/A
Completed N=26
Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer
Source: ClinicalTrials.gov NCT00849186 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Safety of Sunitinib Malate (SM) — .350 proportion of participants
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.
PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery and to see how well it works in treating patients with localized or metastatic kidney cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Sunitinib Malate (SM) |
.350 | — |
| PRIMARY Safety of Surgery After 90 Days of Treatment With SM |
.150 | — |
| SECONDARY Response Rate After 90 Days of Treatment With SM |
.20 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed renal cell carcinoma
- Clinical stage T1b, T2, or T3 tumor with or without nodal or hematogenous metastasis
- Localized or metastatic disease by renal biopsy
- Primary tumor must be amenable to surgical removal
- No history of or known spinal cord compression or carcinomatous meningitis OR evidence of symptomatic brain or leptomeningeal disease by CT scan or MRI
- Treated, stable, and asymptomatic brain metastases are allowed
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- ANC ≥ 1,500/mm^3
- Platelets ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver function abnormalities are due to underlying malignancy)
- Total bilirubin ≤ 1.5 times ULN
- Creatinine 40 mL/min
- Calcium ≤ 10.2 mg/dL
- QTc interval 100 mm Hg despite optimal medical therapy)
- No known HIV positivity
PRIOR CONCURRENT THERAPY:
- Not specified
Data sourced from ClinicalTrials.gov (NCT00849186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.