Randomized Study of Sorafenib Dose Escalation in Patients With Previously Untreated Metastatic Renal Cell Carcinoma
The primary objective of this study is to compare the effectiveness of a dose-escalation regimen (400 to 800mg bid) relative to the standard dosing regimen (400mg bid) of sorafenib given in patients with metastatic RCC.
The secondary objectives are to evaluate the effects of the dose-escalation regimen on the quality of life (QoL) of patients with metastatic RCC and to characterize the safety and tolerability profile of a dose-escalation regimen of sorafenib in patients with metastatic RCC.
|Renal Cell Carcinoma||Drug: Sorafenib Escalated Dose Drug: Sorafenib Standard Dose||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase IIb Study of Sorafenib Dose Escalation in Patients With Previously Untreated Metastatic Renal Cell Carcinoma (RCC)|
- Overall Response Rate (CR + PR) Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. [ Time Frame: Overall response will be measured at baseline and every 8 weeks , unless clinically indicated prior to that, until the end of treatment. ]Response was evaluated via changes from baseline in radiological tumor measurements performed every 8 weeks and at the end of treatment unless clinically indicated prior to that. Confirmatory scans were to be obtained no less than 4 weeks but no more than 6 weeks following initial documentation of objective response. Response was evaluated using RECIST criteria, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions or the appearance of one or more new lesions.
- PFS Rate at 9, 13 and 17 Months [ Time Frame: PFS was to be measured at 9, 13, and 17 months. ]Due to the early study closure and the small sample size, the PFS rate at 9, 13, and 17 months were not evaluated.
- Overall Survival Rate [ Time Frame: Overall survival was measured from day 1 of treatment until the end of treatment and then every 4 months thereafter until death. ]Due to the early study closure and the small sample size, overall survival rate was not evaluated.
- Changes From Baseline in Symptom Burden [ Time Frame: The PCM was administered during screening, at each scheduled visit (approximately every 4 weeks), and at the end of treatment visit. ]
The Patient Care Monitor Version 2.0 (PCM) is an tablet computer based assessment system that measures patient reported outcomes (PROs) in medical patients with a particular emphasis on symptoms related to cancer and its treatment.
The PCM comprises 86 items which include 8 items answered only by females (e.g. menstrual cramping). Each item is presented so that the patient rates the degree to which the item has been a problem in the past week (0 not a problem to 10 as bad as possible).
|Study Start Date:||January 2008|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Group A: Escalated Dose
Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
Drug: Sorafenib Escalated Dose
Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
Other Name: Nexavar
Active Comparator: Group B: Standard Dose
Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
Drug: Sorafenib Standard Dose
Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
Other Name: Nexavar
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557830
|United States, Arkansas|
|Jonesboro, Arkansas, United States, 72401|
|United States, California|
|Wilshire Oncology Medical Group, Inc.|
|La Verne, California, United States, 91750|
|United States, Florida|
|Advanced Medical Specialties|
|Miami, Florida, United States, 33176|
|United States, Georgia|
|Northeast Georgia Cancer Care|
|Athens, Georgia, United States, 30607|
|Peachtree Hematology Oncology Consultants|
|Atlanta, Georgia, United States, 30309|
|Central Georgia Cancer Care|
|Macon, Georgia, United States, 31201|
|Northwest Georgia Oncology Centers|
|Marietta, Georgia, United States, 30060|
|United States, Illinois|
|Mid-Illinois Hematology and Oncology Associates, Ltd.|
|Normal, Illinois, United States, 61761|
|United States, Montana|
|Hematology Oncology Centers of the Northern Rockies|
|Billings, Montana, United States, 59101|
|United States, North Carolina|
|Gaston Hematology and Oncology|
|Gastonia, North Carolina, United States, 28054|
|United States, Oregon|
|Pacific Oncology, PC|
|Beaverton, Oregon, United States, 97006|
|United States, Pennsylvania|
|The Lancaster Cancer Center, Ltd|
|Lancaster, Pennsylvania, United States, 17605|
|United States, Tennessee|
|The West Clinic|
|Memphis, Tennessee, United States, 38120|
|Principal Investigator:||Vasily Assikis, MD||Acorn Cardiovascular, Inc.|