Phase 2
N=80
Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma · Recurrent Renal Cell Carcinoma · Stage IV Renal Cell Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00126594 ↗Enrolled (actual)
80
Serious AEs
73.8%
Results posted
Sep 2016
Primary outcome: Primary: Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) — 30; 25 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sorafenib Tosylate (Drug); Recombinant Interferon Alfa-2b (Biological); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) |
30; 25 | — |
| SECONDARY Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
10; 13; 13; 8; 10; 7 | — |
| SECONDARY Progression-free Survival |
7.39; 7.56 | — |
| SECONDARY Median Overall Survival (OS) |
NA; 27.04 | — |
| SECONDARY Duration of Response for Participants With Stable Disease (N=37) Following Treatment |
5.7 | — |
Summary
This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.
Eligibility Criteria
Inclusion Criteria
- Patients with histologically or cytologically confirmed metastatic clear cell RCC
- Patients must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures >= 20 mm with conventional techniques or >= 10 mm with spiral CT scan
- ECOG performance status = = 1,500/μL
- Platelets >= 100,000/μL
- Hgb > 9.0 g/dL (may be transfused or receive epoetin alfa [e.g., Epogen®] to maintain or exceed this level)
- Total bilirubin = 3.0 g/dL
- Serum creatinine = = 1.5 is due to warfarin therapy; other patients with an INR >= 1.5 are excluded
- Patients must not have a history of severe depression
- Concomitant treatment with rifampin, St. John's wort, and the cytochrome p450 enzyme-inducin antiepileptic drugs (phenytoin, carbamazepine or Phenobarbital)
Data sourced from ClinicalTrials.gov (NCT00126594). 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.