Phase 2
Completed N=25
Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT00267748 ↗
Enrolled (actual)
25
Serious AEs
35.4%
Results posted
Sep 2011
Primary outcomePrimary: Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model — 3.1; 4.4; 8.0; 7.1 Months — p=0.860
Summary
This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment.
The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model |
3.1; 4.4; 8.0; 7.1; 20.7; 8.4 | 0.860 |
| SECONDARY Percentage of Participants With Objective Response (OR) |
32.2; 28.1 | 0.444 |
| SECONDARY Duration of Response (DR) |
12.5; 8.7 | — |
| SECONDARY Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model |
3.5; 6.1; 19.3; 21.8; NA; 28.9 | 0.866 |
Eligibility Criteria
Inclusion Criteria
- Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
- Measurable disease
Exclusion Criteria
- Prior systemic therapy of any kind for advanced renal cell cancer
- History of brain metastases
- Uncontrolled hypertension
Data sourced from ClinicalTrials.gov (NCT00267748). 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.