Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Sorafenib

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth

Sorafenib 400 mg twice daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.

Erlotinib

David Spigel, M.D.

This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.

Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

Randomized Phase II Trial of Sorafenib and Erlotinib or Sorafenib Alone in Patients With Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. 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.

The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Defined as the number of participants with treatment-emergent grade 3/4 adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v3.0

Bayer

OSI Pharmaceuticals

SCRI Development Innovations, LLC

Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.

Sorafenib+Erlotinib

Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.

Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

John D Hainsworth, MD

Progression-free Survival (PFS)

Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.

Overall Response Rate

Anemia

Fatigue

Diarrhea

Dehydration

Rash/Desquamation

Hand-foot skin reaction

Dyspnea

Hyponatremia

Hyperglycemia

Lipase increased

Anorexia

Atrial Fibrillation

Cognitive Disturbance

Confusion

Congestive Heart Failure

Constipation

Dysphagia

Extremity - upper (function)

Hypertension

Cardiac Ischemia/Infarction

Hypokalemia

Hypoxia

Ileus

Infection - Pneumonia

Infection - Wound

Malaise

Nausea

Obstruction, GI

Pain - abdomen

Pain - chest

Pain - musculoskeletal

Perforation, GI

Vomiting

Dizziness

Infection - urinary tract NOS

Neuropathy - cranial

Pain - back

Pain - head/headache

COPD exacerbation

Ocular surgery

Personality change

Respiratory failure

Pulmonary embolism

Sorafenib and Erlotinib

Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability

Overall Study

Spots Global Cancer Trial Database for Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial