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Lung CancerPhase 2NCT00411671

BATTLE Program: Sorafenib in Patients With NSCLC

A Phase 2 study testing Sorafenib in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Sorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteUnited States
Study dates
Nov 2006to Nov 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • The patient is eligible if disease free from a previously treated malignancy, other than a previous NSCLC, for greater than two years. Patients with a history of prior basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are exempt from exclusion.
  • 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.

Who cannot join

  • 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 has uncontrolled seizure disorder, active neurologic disease, or neuropathy >/= grade 2. Patients with meningeal or central nervous System (CNS) involvement by tumor are eligible for the study if the above exclusion criteria are not met.
  • The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
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  • 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.
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 48 hours of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between BAY 43-9006 and oral contraceptives.
  • Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the study results.
  • Known allergy to the investigational agent or any agent given in association with this trial.
  • Concurrent use of St. John's Wort, Rifampicin, and/or ritonavir.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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
Read the 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.

Conditions
Lung Cancer
Being tested
Sorafenib
Keywords
Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, Sorafenib, BAY 43-9006, Battle Program
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SorafenibDrug

    Also called BAY 43-9006

    400 mg By Mouth Twice Daily for 28 Days.

Study groups in NCT00411671
Study groupRoleWhat they receive
SorafenibExperimentalSorafenib 400 mg By Mouth Twice Daily for 28 Days.
Receives: Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 8 weeks

Secondary outcomes (2)

  1. Progression-Free Survival

    The Progression-Free Survival (PFS) was measured from date of randomization until progressive disease (PD) or death respectively.

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

  2. Tumor Response Measured Every 8-weeks

    Tumor responses was measured according to RECIST criteria. Tumor responses were defined as: Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD): steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): at least a 20% increase in the sum of 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.

    Measured: At baseline and then every 8 weeks until treatment discontinuation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00411671
Sponsor's protocol ID
2005-0827
Status last verified
Jan 2016
First submitted
12 Dec 2006
Last updated
11 Feb 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23442309

  • 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.

    PubMed 22586319

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

8-Week Disease Control Rate (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00411671, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016.

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