Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery
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Purpose
RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in treating patients with kidney cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: sunitinib malate Procedure: conventional surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors |
- Response to sunitinib therapy [ Time Frame: 1 year from start of treatment ] [ Designated as safety issue: No ]Defined as a reduction in tumor burden to such an extent that nephrectomy is permitted within 1 year of the start of therapy. No response to sunitinib therapy is defined as a nephrectomy not being permitted within 1 year of the start of therapy or removal from the study for any reason
- The number of patients with any type of complication or adverse event [ Time Frame: within 1 year of the start of therapy ] [ Designated as safety issue: Yes ]The safety of sunitinib will be assessed by recording the number of patients with any type of complication or adverse event within 1 year of the start of therapy.
- Duration of overall response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The duration of overall response is measured from the time measurement criteria are met for Complete Response(CR) or (Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented.
Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started.
| Enrollment: | 30 |
| Study Start Date: | March 2007 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sunitinib |
Drug: sunitinib malate
Sunitinib will be dosed at 50 mg p.o. daily
Other Names:
Procedure: conventional surgery
nephrectomy
|
Detailed Description:
OBJECTIVES:
- To determine the percentage of patients with renal cell carcinoma and unresectable primary tumors who can achieve sufficient tumor response, according to the operating surgeon, to undergo nephrectomy after sunitinib therapy.
- To evaluate the safety of sunitinib in patients with renal cell carcinoma and unresectable primary tumors, including analysis of the morbidity of surgery after sunitinib therapy
- To evaluate the objective response rate of patients with renal cell carcinoma and unresectable primary tumors who receive sunitinib therapy.
OUTLINE: Patients are stratified according to the presence of distant metastases (yes vs no).
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. Surgery is performed if and when primary tumor becomes resectable. Patients with residual and/or metastatic disease may resume sunitinib malate within 8 weeks after surgery.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma (any histology) meeting 1 of the following criteria:
- Metastatic disease
- No evidence of distant metastatic disease on CT scan of chest/abdomen/pelvis, bone scan, and brain imaging (CT scan or MRI)
Unresectable primary tumor due to any of the following factors:
- Large tumor size (> 15 cm)
- Bulky lymphadenopathy (> 4 cm or encasement of renal vessels or great vessels)
- Venous thrombosis (high level/invasive disease requiring inferior vena cava reconstruction or hypothermic circulatory arrest)
- Proximity to vital structures (e.g., mesenteric vasculature)
- No known brain metastases, spinal cord compression, carcinomatous meningitis, or new evidence of brain leptomeningeal disease by CT scan or MRI
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL (transfusion allowed)
- Serum calcium ≤ 12.0 mg/dL
- Creatinine ≤ 2.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No evidence of bleeding diathesis or coagulopathy (hematuria from primary renal tumor allowed)
None of the following within the past 6 months:
- Myocardial infarction
- Severe or unstable angina
- Severe peripheral vascular disease (claudication) or procedure on peripheral vasculature
- Coronary/peripheral artery bypass graft
- New York Heart Association class II-IV congestive heart failure
- Cerebrovascular accident or transient ischemic attack
- Clinically significant bleeding
- Deep venous thrombosis
- Pulmonary embolism
- No hypertension that cannot be controlled by medications to blood pressure < 160/90 mm Hg
- No known HIV positivity or AIDS
- No other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic treatment for renal cell carcinoma
- No other concurrent anticancer agents or therapies, including chemotherapy, biological response modifiers, hormonal therapy, palliative radiotherapy, or immunotherapy
- No concurrent inducers or inhibitors of CYP3A4
- No other concurrent investigational drugs
- No concurrent participation in another clinical trial
Contacts and Locations| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Study Chair: | Brian I. Rini, MD | Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided by Case Comprehensive Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00459979 History of Changes |
| Other Study ID Numbers: | CASE17806, P30CA043703, CASE-17806, CASE-17806-CC209 |
| Study First Received: | April 11, 2007 |
| Last Updated: | October 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Case Comprehensive Cancer Center:
|
clear cell renal cell carcinoma stage III renal cell cancer stage IV renal cell cancer papillary renal cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013