Loading clinical trials...

BATTLE Program: Sorafenib in Patients With NSCLC | Clinical Trials | Clareo Health

COMPLETEDPHASE2

BATTLE Program: Sorafenib in Patients With NSCLC

A Phase II Study of Sorafenib (BAY 43-9006) in Chemorefractory Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT00411671•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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

Detailed Description

BAY 43-9006® (Sorafenib) is an experimental agent designed to stop the growth of cancer cells. In order to enroll in this study, you must also be enrolled in Protocol 2005-0823: A Biomarker-integrated study in Chemorefractory patients with advanced Non-Small Cell Lung Cancer. Protocol 2005-0823 is the screening study in a group of studies called the BATTLE program. Participants in Protocol 2005-0823 are assigned to one of the treatment studies. The results of your tumor analysis helped the study doctor determine to assign you to this particular treatment study. While on study, you will take 2 tablets of sorafenib each morning, and again each evening. Sorafenib should be taken with about 1 cup of water on an empty stomach (either 1 hour before a meal or 2 hours after a meal). Sorafenib must be swallowed whole without chewing. If you feel nauseated before or after taking the medication, anti-nausea medications should be used. If you miss a dose, you should skip it and take the next scheduled dose at the right time. Your medication should be stored at room temperature. Every 4 weeks (1 cycle) your complete medical history will be recorded and you will have a physical exam, including measurement of vital signs (blood pressure, pulse, temperature, and breathing rate) and weight. Blood (about 2 teaspoons) and urine will be drawn for routine tests. You will have a performance status evaluation (questions about your ability to perform everyday activities) and blood drawn (about 1-2 teaspoons) to check your blood clotting function. Your study doctor will also ask you about any medications you are taking and your smoking history. You will be asked to record your weekly blood pressure for the first 6 weeks of study treatment. The study doctor or research nurse will review the log at each clinic visit. Every 2 cycles, your tumor will be evaluated by chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans to evaluate the status of the disease. If you are taking Coumadin® (warfarin), you will have blood drawn (about 1-2 teaspoons) to check your blood clotting function weekly for the first 6 weeks of treatment and then every cycle after that. You may continue receiving sorafenib for as long as the cancer responds to study treatment. Your doctor may decide to take you off this study if you experience intolerable side effects or your medical condition gets worse. If you stop study treatment, you will be allowed to enroll in one of the remaining 3 protocols of the BATTLE program. After you have stopped taking the study treatment, you will have a physical exam, including measurement of vital signs. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will also have blood drawn (about 1-2 teaspoons) to check your blood clotting function. You will have a performance status evaluation, a chest x-ray, and a CT or MRI scan. Following this evaluation, you will be contacted by telephone every 3 months for up to 3 years, to see how you are doing. You have the right to leave the study at any time. If you choose to stop participating in this study, you should contact the study chair and/or research nurse. Your doctor may decide to take you off this study if your medical condition gets worse and/or you are unable to comply with study requirements. This is an investigational study. Sorafenib (BAY 43-9006) has been approved by the FDA for treatment of advanced renal cell cancer; however, it's use in this research study is investigational. Up to 62 patients will take part in this multicenter study. Up to 50 will be enrolled at M. D. Anderson.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration.
•2. 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).
•3. The patient has uni-dimensionally measurable NSCLC.
•4. Karnofsky performance status \>/= 60 or ECOG performance status 0-2
•5. The patient has biopsy accessible tumor.
•6. 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.
•7. 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.
•8. 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.
•9. The patient has Prothrombin time (PT) \< 1.5 \* upper limit of normal
•10. 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.
+4 more criteria

Exclusion Criteria

•1. The patient has received prior investigational therapy, chemotherapy, surgery, or radiotherapy within 4 weeks of initiating study drug
•2. The patient has undergone prior thoracic or abdominal surgery within 28 days of study entry, excluding prior diagnostic biopsy.
•3. 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.
•4. 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.
•6. The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
•7. Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
•8. The patient is actively taking herbal remedies or over-the-counter biologics (e.g., shark cartilage, high dose antioxidants).
•9. 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.
•10. Prior hemoptysis or bleeding diathesis.
•11. Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg)
+9 more criteria

Locations (1)

UT MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

November 1, 2006

Primary Completion Date

November 1, 2012

Completion Date

November 1, 2012

Last Updated

February 11, 2016

Enrollment

105

ACTUAL participants

Conditions

Lung Cancer

Interventions

Sorafenib

DRUG

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

NCT05198830

Lung AdenocarcinomaLung Large Cell Carcinoma+2 more

View study

RECRUITINGPHASE1

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

BATTLE Program: Sorafenib in Patients With NSCLC

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)