BATTLE Program: Sorafenib in Patients With NSCLC

NCT00411671 | Completed Phase 2 Results DMC

• 1 other identifier: 2005-0827
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen. Secondary Objective: The secondary objectives of this study will be to:
• Determine the overall response rate
• Determine the overall survival
• Determine the time to disease progression
• Assess the safety/toxicity of the study treatment
• Assess biomarker modulation in the tumor tissue and serum samples from the treatment.
• Assess plasma and intra-tumor concentrations of study treatment

Conditions

Lung Cancer

Keywords

Lung Cancer; Non-Small Cell Lung Cancer; NSCLC; Sorafenib; BAY 43-9006; Battle Program

Outcome Measures

Primary Outcomes (1)

• 8-Week Disease Control Rate

  The disease control rate (DCR) was defined as the proportion of patients who did not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease (PD) at 8 weeks. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  Baseline to 8 weeks

Secondary Outcomes (2)

• Progression-Free Survival

  From date of randomization until PD or death respectively, up to 3 years

• Tumor Response Measured Every 8-weeks

  At baseline and then every 8 weeks until treatment discontinuation.

Study Arms (1)

Sorafenib

EXPERIMENTAL

Sorafenib 400 mg By Mouth Twice Daily for 28 Days.

Drug: Sorafenib

Interventions

Sorafenib DRUG

400 mg By Mouth Twice Daily for 28 Days.

Also known as: BAY 43-9006

Sorafenib

Eligibility Criteria

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

You may qualify if:

• The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration.
• The patient has a diagnosis of either stage IIIB, stage IV, or advanced, incurable NSCLC, and failed at least one front-line metastatic NSCLC chemotherapy regimen. (Patients who have failed adjuvant or locally advanced therapy within 6 months are also eligible to participate in study).
• The patient has uni-dimensionally measurable NSCLC.
• Karnofsky performance status \>/= 60 or ECOG performance status 0-2
• The patient has biopsy accessible tumor.
• The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) \>/= 1,500/mm\^3, platelet count \>/= 100,000/mm\^3, white blood count (WBC) \>/= 3,000/ mm\^3, and hemoglobin \>/= 9 g/dL.
• The patient has adequate hepatic function as defined by a total bilirubin level \</= 1.5 \* the upper limit of normal, and alkaline phosphatase, AST or ALT \</= 2.5 \* the upper limit of normal.
• The patient has adequate renal function as defined by a serum creatinine level \</= 1.5 mg/dL or a calculated creatinine clearance of \>/= 60cc/minute.
• The patient has Prothrombin time (PT) \< 1.5 \* upper limit of normal
• If patient has brain metastasis, they must have been stable (treated or asymptomatic) for at least 4 weeks after radiation if treated with radiation and not have used steroids for at least 1 week. Re-imaging performed after 2 weeks, upon completion of radiation therapy.
• The patient is \>/= 18 years of age.
• The patient has signed informed consent.
• Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.Childbearing potential will be defined as women who have had menses within the past 12 months,who have not had tubal ligation or bilateral oophorectomy.Should a woman become pregnant or suspect that she is pregnant while participating in this study,she should inform her treating physician immediately.The patient,if a man,agrees to use effective contraception or abstinence.
• Subject must be considered legally capable of providing his or her own consent for participation in this study.

You may not qualify if:

• The patient has received prior investigational therapy, chemotherapy, surgery, or radiotherapy within 4 weeks of initiating study drug
• The patient has undergone prior thoracic or abdominal surgery within 28 days of study entry, excluding prior diagnostic biopsy.
• The patient has received radiation therapy to the measurable tumor within 6 months. Patients are allowed to have local irradiation for the management of tumor-related symptoms (bones, brain). However, if a patient has active new disease growing in the previously irradiated site, the patient will be eligible to participate in the study.
• The patient has a significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure (New York Heart Association Functional Classification class II or worse), recent myocardial infarction within 3 months, unstable angina, active infection (i.e. currently treated with antibiotics), uncontrolled hypertension). Patients with controlled diabetes will be allowed. Patient must be able to undergo procedure for tissue acquisition.
• The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
• Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
• The patient is actively taking herbal remedies or over-the-counter biologics (e.g., shark cartilage, high dose antioxidants).
• Patients will be allowed to have prior biologic (i.e. Vascular endothelial growth factor (VEGF), epidermal growth factor family (EGFR), etc.) therapy. However, the patient will be excluded from a given study if he/she has received the same therapy as the clinical trial (i.e. If a patient has been previously treated with bevacizumab, they are allowed to enroll in any of the 4 studies. If a patient has been previously treated with erlotinib, they are excluded from the clinical trials with erlotinib). In addition, if a patient has been previously treated with gefitinib (Iressa), they are excluded from the clinical trials with erlotinib.
• Prior hemoptysis or bleeding diathesis.
• Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg)
• Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
• History of seizure disorder requiring medication (such as steroids or anti-epileptics).
• History of organ allograft and bone marrow transplant
• Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors \[Ta, Tis \& T1\] or other malignancies curatively treated \> 3 years prior to entry).
• Patients with clinically significant bleeding (e.g., gastrointestinal bleeding) within the past month prior to study entry are ineligible.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• United States Department of Defense: collaborator
• Bayer: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Tam AL, Kim ES, Lee JJ, Ensor JE, Hicks ME, Tang X, Blumenschein GR, Alden CM, Erasmus JJ, Tsao A, Lippman SM, Hong WK, Wistuba II, Gupta S. Feasibility of image-guided transthoracic core-needle biopsy in the BATTLE lung trial. J Thorac Oncol. 2013 Apr;8(4):436-42. doi: 10.1097/JTO.0b013e318287c91e.

  PMID: 23442309 DERIVED

• Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR Jr, Tsao A, Stewart DJ, Hicks ME, Erasmus J Jr, Gupta S, Alden CM, Liu S, Tang X, Khuri FR, Tran HT, Johnson BE, Heymach JV, Mao L, Fossella F, Kies MS, Papadimitrakopoulou V, Davis SE, Lippman SM, Hong WK. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov. 2011 Jun;1(1):44-53. doi: 10.1158/2159-8274.CD-10-0010. Epub 2011 Jun 1.

  PMID: 22586319 DERIVED

Related Links

• MD Anderson Cancer Center website

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

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

Results Point of Contact

• Title: George Blumenschein, MD / Professor, Thoracic/Head & Neck Med Oncology
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• George Blumenschein, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 14, 2006
• Study Start: November 1, 2006
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 11, 2016
• Results First Posted: February 11, 2016

Record last verified: 2016-01

Locations

US (1)