Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00754923 | Terminated Phase 2 Results DMC

• 2 other identifiers: OSU-08017NCI-2011-03192
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib works in treating non-smokers or former light smokers with relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival at 6 Months

  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate

  6 months

Secondary Outcomes (3)

• Overall Survival Rate

  Up to 2 years

• Incidence of Adverse Events Sssessed by Common Terminology Criteria for Adverse Events (CTCAE)

  Up to 2 years

• Mutational Status for EGFR or Kras

  up to 2 years

Study Arms (1)

Treatment: Sorafenib

EXPERIMENTAL

Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.

Drug: sorafenib

Interventions

sorafenib DRUG

administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.

Also known as: Nexavar, sorafenib tosylate

Treatment: Sorafenib

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Stage IIIB or IV disease * Recurrent disease after prior surgery, chemotherapy, or radiotherapy * No squamous cell histology or mixed tumor with \> 50% squamous cells * Non-smoker (smoked ≤ 100 cigarettes in lifetime) OR former light smoker (smoked \> 100 cigarettes but ≤ 10 pack years AND quit smoking ≥ 1 year ago) * No known brain metastasis * Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis PATIENT CHARACTERISTICS: * ECOG(Eastern Cooperative Oncology Group)performance status 0-2 * ANC (Absolute Neutrophil Count)≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * ALT (Alanine Aminotransferase Test) and AST (Aspartate Aminotransferase Test) ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 1.5 mg/dL * Creatinine clearance ≥ 50 mL/min * INR (International Normalized Ratio) \< 1.5 OR PT/PTT (Prothrombin time/partial thromboplastin time)normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception prior to, during, and for ≥ 3 months after completion of study treatment * No cardiac disease, including any of the following: * New York Heart Association class III-IV congestive heart failure * Unstable angina (anginal symptoms at rest) * New-onset angina within the past 3 months * Myocardial infarction within the past 6 months * No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 90 mm Hg) despite optimal medical management * No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months * No pulmonary hemorrhage or bleeding event ≥ CTCAE (Common Terminology Criteria for Adverse Events)grade 2 within the past 4 weeks * No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks * No active clinically serious infection \> CTCAE grade 2 * No serious non-healing wound, ulcer, or bone fracture * No evidence or history of bleeding diathesis or coagulopathy * No known HIV infection or chronic hepatitis B or C * No other malignancy except for any of the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Other cancer from which the patient has been disease-free for ≥ 5 years with a low probability of recurrence * No condition that impairs the patient's ability to swallow whole pills * No malabsorption problems * No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study * No significant traumatic injury within the past 4 weeks PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than one prior systemic chemotherapy treatment for metastatic disease * Prior treatment with EGFR inhibitors is not considered chemotherapy * More than 4 weeks since prior major surgery or open biopsy * No prior sorafenib tosylate * No concurrent St. John's wort or rifampin * Concurrent anticoagulation with warfarin or heparin allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Bayer: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

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

Limitations and Caveats

The study was discontinued, after withdrawal from the sponsor due to slow accrual. The discovery of EGFR mutations changed the scope of the trial.

Results Point of Contact

• Title: Miguel Villalona
• Organization: OSU

miguel.villalona@osumc.edu

614-366-5068

Study Officials

• Miguel A. Villalona, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: 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: September 17, 2008
• First Posted: September 18, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 6, 2019
• Results First Posted: June 4, 2014

Record last verified: 2019-02

Locations

US (1)