Phase IV Randomization to On-Going Treatment to Evaluate Sustained Sorafenib

NCT00352859 | Terminated Phase 4

• 1 other identifier: 12178
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Renal Cell

Keywords

Cancer; Renal Cell Cancer; RCC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  After 192 progression or death events

Secondary Outcomes (6)

• Disease Control Rate (DCR)

  After start of treatment

• Overall Best Response

  Until 30 days after termination of active therapy

• Duration of response

  Time from initial Response to documented Tumor Progression

• 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

• Overall Survival (OS)

  Time from the date of randomization to date of death

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon

Arm 2

EXPERIMENTAL

Drug: Gemcitabine or Interferon (only)

Interventions

Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon DRUG

Continue sorafenib with addition of gemcitabine or interferon

Arm 1

Gemcitabine or Interferon (only) DRUG

Discontinue Sorafenib and receive Gemcitabine or Interferon only

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients must not have experienced more than three weeks from documented disease progression to randomization
• Any medical condition requiring the use of systemic corticosteroids during IFN therapy
• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1) or any cancer curatively treated within the last three years prior to study entry
• Severe renal impairment or receiving dialysis
• More than a two week interruption in sorafenib dosing immediately prior to randomization
• Patients with a best response of disease progression on their previous course of sorafenib
• Patients who meet the MSKCC high risk category at randomization
• Hemorrhagic episode \>= Grade 2 NCI CTC AE v3.0 within last six months
• History of cardiac disease: congestive heart failure\> NYHA class 2; active cardiovascular disease (MI more than six months prior to study entry is allowed); cardiac arrhythmia requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
• Active clinically serious bacterial or fungal infections (\>= Grade 2 NCI CTCAE v3.0)
• Known history of Human Immunodeficiency Virus (HIV) infection or chronic hepatitis B or C
• Symptomatic metastatic brain or meningeal tumors unless the patient is \> six months from definitive therapy, has a negative CNS imaging study within four weeks of study entry, and is clinically stable off steroids. The patient must not be undergoing acute steroid taper
• Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Kansas City, Missouri, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasms

Interventions

Sorafenib; Interferons; Gemcitabine; Single Person

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2006
• First Posted: July 17, 2006
• Study Start: August 1, 2006
• Study Completion: November 1, 2006
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

US (1)