Phase 2
N=17
Celecoxib and Recombinant Interferon Alfa-2b in Metastatic Kidney Cancer Who Have Undergone Surgery
Renal Cell Cancer · Stage IV Renal Cell Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01158534 ↗Enrolled (actual)
17
Serious AEs
11.8%
Results posted
Jul 2012
Primary outcome: Primary: Objective Response Rate Assessed by RECIST Criteria. — 0; 3; 5; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- celecoxib (Drug); recombinant interferon alfa-2b (Biological); polymerase chain reaction (Other); laboratory biomarker analysis (Other); reverse transcriptase-polymerase chain reaction (Other); immunologic technique (Other); immunohistochemistry staining method (Other); flow cytometry (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate Assessed by RECIST Criteria. |
0; 3; 5; 9 | — |
| SECONDARY Overall Survival |
14.4 | — |
| SECONDARY Duration of Response |
8.7 | — |
| SECONDARY Progression-free Survival |
5.6 | — |
| SECONDARY Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months |
— | — |
Summary
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Recombinant interferon alfa-2b may interfere with the growth of cancer cells and slow the growth of kidney cancer. Giving celecoxib together with recombinant interferon alpha-2b may kill more tumor cells and be an effective treatment for metastatic kidney cancer.
PURPOSE: This phase II trial is studying how well giving celecoxib together with recombinant interferon alfa-2b works in treating patients with metastatic kidney cancer who have undergone surgery.
Eligibility Criteria
Criteria
- Patients must have histologically-confirmed metastatic renal cell carcinoma
- Patients must have 3+ (on a scale of 0 to 3+) COX-2 staining in >= 10% of the RCC tumor cells from baseline tumor tissue
- Patients must not have received any prior cytokine therapy for renal cell carcinoma
- Patients may have received any number of prior non-cytokine systemic therapies for metastatic RCC
- Patients must have undergone nephrectomy (radical or partial)
- All patients must be at least 2 weeks from prior systemic therapy, radiation or major surgery
- Patients must have measurable disease per RECIST criteria
- ECOG performance status 0 or 1
- Leukocytes >= 3,000/mL
- Absolute neutrophil count >= 1,500/mL
- Platelets >= 75,000/mL
- Total bilirubin = = 70%
Data sourced from ClinicalTrials.gov (NCT01158534). 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.