Carcinoma, Renal Cell
Conditions
Keywords
Cancer, Renal Cell Cancer, RCC
Brief summary
The purpose of this study is to see if taking interferon or gemcitabine along with sorafenib will stop the advanced renal cell cancer from becoming worse in some people. To do this, sorafenib along with gemcitabine or interferon will be compared to treatment with gemcitabine or interferon alone. More safety information on sorafenib will be also collected. About 260 patients with progressed renal cell cancer will be in this study.
Interventions
DRUGNexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon
Continue sorafenib with addition of gemcitabine or interferon
DRUGGemcitabine or Interferon (only)
Discontinue Sorafenib and receive Gemcitabine or Interferon only
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients above 18 years of age with advanced RCC who have received sorafenib as their first and only systemic anti-tumor therapy for RCC prior to randomization * Patients must have previously tolerated a minimum dose of sorafenib 400 mg daily for at least six weeks prior to study entry and have radiographically documented progressive disease while on sorafenib * Patients must have experienced clinical benefit, partial response, complete response or stable disease during their previous course of sorafenib therapy * Life expectancy \> 12 weeks * Patients must meet the Memorial Sloan-Kettering Cancer Center (MSKCC) risk category of low or medium at randomization * Patients must give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice * Patients must have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) * Patients must not have brain metastases * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 * In addition, the following patients may be included, provided all other inclusion and
Exclusion criteria
are met * Patients who have received the vaccines cG250 (monoclonal antibody to carbonic anhydrase IX) or HSPPC-96 (Heat Shock Protein Peptide Complex 96) are eligible provided that they have received no other systemic anti-cancer therapy * Patients who were enrolled in the ARCCS treatment protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | After 192 progression or death events |
Secondary
| Measure | Time frame |
|---|---|
| Overall Best Response | Until 30 days after termination of active therapy |
| Duration of response | Time from initial Response to documented Tumor Progression |
| Disease Control Rate (DCR) | After start of treatment |
| Overall Survival (OS) | Time from the date of randomization to date of death |
| Adverse Event Collection and Tolerability | Throughout the whole study |
| Time to response | Time from the date of randomization to date that an objective tumor response (PR or CR) according to RECIST criteria is first documented |
Countries
United States
Outcome results
None listed