Trial Condition(s):

Carcinoma, Non-Small-Cell Lung

A Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel plus or minus Sorafenib (BAY43-9006) in Chemonaive Patients with Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

Bayer Identifier:

12621

ClinicalTrials.gov Identifier:

NCT00558636

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

The purpose of this study conducted in Asia-Pacific was to evaluate the efficacy and safety of Sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for chemonaive patients with unresectable stage IIIB (with effusion) or stage IV NSCLC. However, as indicated below, the study was terminated prematurely when the results from Study 11961 (NCT00300885), an earlier Phase 3 study of similar design in subjects with advanced NSCLC, showed an overall lack of efficacy and increased mortality in subjects with squamous subtype. The data available is presented as descriptive analyses, due to the limitations of implementing the statistical analysis plan.

Inclusion Criteria
- Stage IIIB (with cytologically confirmed  malignant pleural or pericardial effusion) or Stage IV histological or cytological confirmation of NSCLC (thoracentesis or pericardiocentesis is not necessary if a biopsy of the original tumor is available to confirm diagnosis of NSCLC)
- Patients must have measurable disease according to response evaluation criteria in solid tumors (RECIST) criteria
- Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study drug, but the lesion which undergo RECIST assessment should not be in the field of the prior radiation
- Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study drug
- 18 years and above
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 
- Life expectancy of at least 12 weeks 
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
- Hemoglobin 9.0 g/dl 
- Absolute neutrophil count (ANC) 1,500/mm3
- Platelet count 100,000/mm3
- Total bilirubin < 1.5 times the upper limit of normal
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement)
- international normalized ratio (INR) < 1.5 and activated or adjusted partial thromboplastin time (APTT) within normal limits (1.2 times the lower limit of normal (LLN) to 1.2 times the upper limit of normal (ULN))
- Creatinine </= 1.5 times the upper limit of normal
- Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures
Exclusion Criteria
- Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for  any current or prior diagnosis of NSCLC
- Cardiac disease: Congestive heart failure > class II New York Heart Association (NYHA). Patients must not have unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months 
- Known brain metastasis. Patients with neurological symptoms should undergo at Computed Tomography (CT) scan/Magnetic Resonance Imaging (MRI) of the brain to exclude brain metastasis
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 
- Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
- Known human immunodeficiency virus (HIV) infection 
- Active clinically serious infections > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 
- Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
- Serious, non-healing wound, ulcer, or bone fracture
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of  first dose of study drug
- Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids.  Low dose warfarin (1 mg daily, oral) is permitted if the INR remains < 1.5.  Low-dose aspirin is permitted
- Known or suspected allergy to sorafenib or any agent given in the course of this trial 
- Cancer other than NSCLC within 5 years prior to start of study treatment, EXCEPT cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumors
- Concurrent cancer that is distinct in primary site or histology from NSCLC
- Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results
- Any condition that impairs patients ability to swallow whole pills 
- Any malabsorption condition 
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing. The investigator should advise the patient how to achieve an adequate contraception

Trial Summary

Enrollment Goal
91
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Sun Yat-sen University Cancer Center

Guangzhou, China, 510060

Status
Completed
 
Locations

Fudan University Shanghai Cancer Center

shanghai, China, 200032

Status
Terminated
 
Locations

PLA 81 Hospital

Nanjing, China, 210003

Status
Completed
 
Locations

Tata Memorial Hospital

Mumbai, India, 400012

Status
Terminated
 
Locations

Changhua Christian Hospital

Changhua, Taiwan, China, 500

Status
Completed
 
Locations

National Cancer Center

Singapore, Singapore, 169610

Status
Completed
 
Locations

Nanfang Hospital.

Guangzhou, China, 510515

Status
Completed
 
Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100021

Status
Completed
 
Locations

Peking University Cancer Hospital

Beijing, China, 100142

Status
Terminated
 
Locations

Peking Union Medical College Hospital

Beijing, China, 100730

Status
Completed
 
Locations

Shanghai Pulmonary Hospital, Tongji University

shanghai, China, 200433

Status
Completed
 
Locations

Sir Run Run Shaw Hospital

Hangzhou, China, 310016

Status
Completed
 
Locations

Zhejiang Cancer Hospital

Hangzhou, China, (310022),

Status
Completed
 
Locations

Southwest Hospital of 3rd Military Medical University.

Chongqing, China, 400038

Status
Completed
 
Locations

National Cancer Center

Gyeonggi-do, South Korea, 410-769

Status
Terminated
 
Locations

Korea University Anam Hospital

Seoul, South Korea, 136-705

Status
Terminated
 
Locations

Sir Ganga Ram Hospital

New- Delhi, India, 110008

Status
Terminated
 
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 100

Status
Completed
 
Locations

National University Cancer Institute, Singapore

Singapore, Singapore, 119228

Status
Completed
 
Locations

Chulalongkorn Hospital

Bangkok, Thailand, 10330

Status
Completed
 
Locations

Ramathibodhi Hospital

Bangkok, Thailand

Status
Completed
 
Locations

Investigative Site

Shatin, China

Status
Terminated
 

Trial Design