Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT00126659
Status:
TERMINATED
Last Update Posted:
2018-11-20
First Post:
2005-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sorafenib in Treating Patients Who Are Undergoing Surgery for Metastatic Kidney Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Neoadjuvant Clinical Trial to Evaluate the Efficacy of BAY 43-9006 (Sorafenib) in Metastatic Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sorafenib 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 sorafenib before and after surgery may be an effective treatment for kidney cancer. This phase II trial is studying how well sorafenib works in treating patients who are undergoing surgery for metastatic kidney cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. Efficacy of BAY 43-9006 (sorafenib tosylate) by evaluating response rate. II. Toxicities of BAY 43-9006 in metastatic renal cell carcinoma (RCC). III. Intraoperative and peri/postoperative safety of BAY 43-9006.
SECONDARY OBJECTIVES:
I. Time to progression. II. Duration of response. II. Overall Survival.
TERTIARY OBJECTIVES:
I. Tissue expression of VEGFR-2/phospho-VEGFR-2, PDGFR/phospho-PDGFR, FGFR/phospho-FGFR, ERK/phospho-ERK, RAF-1/phospho-RAF-1, p38/phospho-p38, Akt/phospho-Akt, P27, Ki67, TGF-alpha, and TUNEL pre- and post- therapy (optional studies).
II. Oligonucleotide analysis of tissue pre- and post-therapy (optional studies).
OUTLINE: This is a non-randomized study. Patients are sequentially assigned to 1 of 3 treatment groups.
GROUP I: Patients undergo cytoreductive nephrectomy on day 1. Patients then receive oral sorafenib twice daily on days 15-84.
GROUP II: Patients receive oral sorafenib twice daily on days 1-7. Patients undergo cytoreductive nephrectomy on day 8. Patients then receive oral sorafenib twice daily on days 22-84.
GROUP III: Patients receive oral sorafenib twice daily on days 1-28. Patients undergo cytoreductive nephrectomy on day 29. Patients then receive oral sorafenib twice daily on days 43-84.
In all groups, patients with stable or regressing disease continue to receive oral sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Some patients may continue treatment for longer than 1 year at the discretion of the investigator.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 45 patients (15 per treatment group) will be accrued for this study within 1 year.
I. Efficacy of BAY 43-9006 (sorafenib tosylate) by evaluating response rate. II. Toxicities of BAY 43-9006 in metastatic renal cell carcinoma (RCC). III. Intraoperative and peri/postoperative safety of BAY 43-9006.
SECONDARY OBJECTIVES:
I. Time to progression. II. Duration of response. II. Overall Survival.
TERTIARY OBJECTIVES:
I. Tissue expression of VEGFR-2/phospho-VEGFR-2, PDGFR/phospho-PDGFR, FGFR/phospho-FGFR, ERK/phospho-ERK, RAF-1/phospho-RAF-1, p38/phospho-p38, Akt/phospho-Akt, P27, Ki67, TGF-alpha, and TUNEL pre- and post- therapy (optional studies).
II. Oligonucleotide analysis of tissue pre- and post-therapy (optional studies).
OUTLINE: This is a non-randomized study. Patients are sequentially assigned to 1 of 3 treatment groups.
GROUP I: Patients undergo cytoreductive nephrectomy on day 1. Patients then receive oral sorafenib twice daily on days 15-84.
GROUP II: Patients receive oral sorafenib twice daily on days 1-7. Patients undergo cytoreductive nephrectomy on day 8. Patients then receive oral sorafenib twice daily on days 22-84.
GROUP III: Patients receive oral sorafenib twice daily on days 1-28. Patients undergo cytoreductive nephrectomy on day 29. Patients then receive oral sorafenib twice daily on days 43-84.
In all groups, patients with stable or regressing disease continue to receive oral sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Some patients may continue treatment for longer than 1 year at the discretion of the investigator.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 45 patients (15 per treatment group) will be accrued for this study within 1 year.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-02920 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000438709 | None | None | View | |
| 2004-0516 | OTHER | M D Anderson Cancer Center | View | |
| 6630 | OTHER | CTEP | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CM62202 | NIH | None | https://reporter.nih.gov/quic… | View |