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BATTLE-FL: A Biomarker-Integrated Study in Patients With Advanced Non-Small Cell Lung Cancer Treated in the Front-Line (FL) Setting


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

BATTLE-FL: A Biomarker-Integrated Study in Patients With Advanced Non-Small Cell Lung Cancer Treated in the Front-Line (FL) Setting


The Study Drugs:

Carboplatin is designed to interfere with the growth of cancer cells by stopping cell
division, which may cause the cells to die.

Pemetrexed is designed to block enzymes in the body that play a part in tumor growth.

Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary
for tumor growth. This may prevent or slow down the growth of cancer cells.

Cetuximab is designed to prevent or slow down the growth of cancer cells by blocking
proteins inside the cancer cell, called the epidermal growth factor receptor (EGFR).

Cixutumumab is a monoclonal antibody, which means that it attaches to specific targets on
cancer cells. These targets are called IGF-1R and help the cancer cells grow and divide.
Cixutumumab is designed to block these receptors on tumor cells that may cause tumors to
grow.

Study Groups and Drug Administration (Combination Therapy):

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the roll of dice) to 1 of 4 groups. You will have an equal chance of being assigned
to each group. Each cycle is 21 days (+/- 5 days).

- If you are in Group 1, you will receive carboplatin and pemetrexed on Day 1 of each
cycle. Carboplatin will be given by vein over 10 minutes. Pemetrexed will be given by
vein over 30 minutes.

- If you are in Group 2, you will receive bevacizumab, carboplatin, and pemetrexed on Day
1 of each cycle. Bevacizumab will be given by vein over about 90 minutes for the first
dose, about 60 minutes for the second dose, and about 30 minutes for all other doses.
Carboplatin will be given by vein over 10 minutes. Pemetrexed will be given by vein
over 30 minutes.

- If you are in Group 3, you will receive cetuximab on Days 1, 8, and 15 of each cycle.
The first dose of cetuximab given by vein over about 120 minutes. If it is well
tolerated, each additional infusion will be given over about 60 minutes. You will also
receive carboplatin and pemetrexed on Day 1 of each cycle. Carboplatin will be given
by vein over 10 minutes. Pemetrexed will be given by vein over 30 minutes.

- If you are in Group 4, you will receive cixutumumab, carboplatin, and pemetrexed on Day
1 of each cycle. Cixutumumab is given by vein over 60 minutes. Carboplatin will be
given by vein over 10 minutes. Pemetrexed will be given by vein over 30 minutes.

Study Visits During Combination Therapy:

If you are in Group 4, before you begin receiving study drugs, you will have a hearing test.

On Day 1 (+/- 5 days) of Cycles 1, 2, and 4:

- You will have a physical exam, including measurement of your weight and vital signs.

- You will be asked about any drugs you may be taking and any side effects you may be
having.

- Your performance status will be recorded.

- Blood (about 3 teaspoons) will be drawn for routine tests.

On Days 8 and 15 of Cycle 1:

-If you are in Group 3, blood (about 1 teaspoon) will be drawn for routine tests.

On Day 1 of Cycle 3:

- You will have a physical exam, including measurement of your weight and vital signs.

- You will be asked about any drugs you may be taking and any side effects you may be
having.

- Your performance status will be recorded.

- Blood (about 3 teaspoons) will be drawn for routine tests.

- You will have a CT scan and/or MRI scan of the chest (and abdomen if the doctor thinks
it is needed) to check the status of the disease.

- You will have an MRI scan of the brain.

- You will have a chest x-ray to check the status of the disease.

At any time your doctor thinks it may be needed, blood (about 1 teaspoon) will be drawn to
check how well your blood clots.

Maintenance Therapy:

After you have completed 4 cycles of combination therapy, you may be eligible for
maintenance therapy.

If you are in Group 1,you will receive pemetrexed by vein over 10 minutes on Day 1 (± 5
days) of every 21-day cycle.

If you are in Group 2, you will receive pemetrexed by vein over 10 minutes and bevacizumab
over about 30 minutes on Day 1 (± 5 days) of every 21-day cycle.

If you are in Group 3, you will receive pemetrexed by vein over about 10 minutes on Day 1 (±
5 days) of every 21-day cycle. You will receive cetuximab by vein over about 60 minutes
every 14 days.

If you are in Group 4, you will receive pemetrexed by vein over about 10 minutes and
cixutumumab by vein over about 60 minutes on Day 1 (± 5 days) of every 21-day cycle.

Study Visits During Maintenance Therapy:

On Day 1 of each cycle:

- You will have a physical exam, including measurement of your weight and vital signs.

- You will be asked about any drugs you may be taking and any side effects you may be
having.

- Your performance status will be recorded.

- Blood (about 3 teaspoons) will be drawn for routine tests.

- You will have a CT scan and/or MRI scan of the chest (and abdomen if the doctor thinks
it is needed) to check the status of the disease.

- You will have an MRI scan of the brain.

- You will have a chest x-ray to check the status of the disease.

Length of Study:

You may continue taking the study drug(s) for as long as the doctor thinks it is in your
best interest. You will no longer be able to take the study drug if the disease gets worse
or intolerable side effects occur.

Your participation on the study will be over once you have completed the end-of-dosing visit
and follow-up.

End-of-Dosing Visi:t

When you go off study for any reason, you will have an end-of-dosing visit. The following
tests and procedures will be performed:

- Your medical history will be recorded.

- You will have a complete physical exam, including measurement of your weight and vital
signs.

- You will be asked about any drugs you may be taking and any side effects you may be
having.

- Your performance status will be recorded.

- Blood (about 3 teaspoons) and urine will be collected for routine tests.

- You will have a CT scan and/or MRI of the chest (and abdomen if the doctor thinks it is
needed) to check the status of the disease.

- You will have an MRI scan of the brain.

- You will have a chest x-ray.

- You will have an ECG.

- If you are in Group 4, you will have a hearing test.

Follow-Up:

You will have follow-up every 4 weeks after you are no longer taking the study drugs. You
will be contacted at a clinic visit or by phone. You will be called every 3 months for up
to 3 years and asked about any cancer treatments you may be receiving. This phone call
should take about 10 minutes.

This is an investigational study. Carboplatin and pemetrexed are FDA approved and
commercially available for the treatment of certain types of NSCLC. Bevacizumab is FDA
approved and commercially available for treatment of certain types of colon or rectal
cancer, NSCLC, and renal cell carcinoma. Cetuximab is FDA approved for certain types of
head and neck cancers and colorectal cancer. Cixutumumab is not FDA approved or commercially
available. At this time, cixutumumab is only being used in research.

Up to 300 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. The patient has a diagnosis of pathologically confirmed nonsquamous (nonpredominant
squamous) NSCLC by tumor biopsy and/or fine-needle aspiration. Mixed tumors will be
categorized by the predominant cell type; if small cell elements are present, the
patient is ineligible.

2. The patient has a diagnosis of either stage IIIB or stage IV NSCLC or has recurrent
NSCLC and is not a candidate for curative treatment. Patients may not have had
chemotherapy for front-line NSCLC treatment.

3. The patient has measurable NSCLC.

4. The patient's ECOG performance status is
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, 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 X the upper limit of normal (Serum bilirubin >/= 1.5x Upper Limit of Normal in
the setting of known Gilbert's disease is allowed), and alkaline phosphatase, AST and
ALT present.

8. The patient has adequate renal function as defined as CrCl of at least 45ml/min.

9. If patient has brain metastasis, they must have been stable (treated and/or
asymptomatic) and off steroids for at least 2 weeks.

10. The patient is >/= 18 years of age.

11. The patient has signed informed consent.

12. Women of childbearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) for the duration of study participation
and for six (6) months after discontinuation of the study drugs. Childbearing
potential will be defined as women who have had menses within the past 12 months, who
have not had tubal ligation, hysterectomy 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 for the duration of study participation
and for six (6) months after discontinuation of the study drugs.

13. The ability to interrupt the use of NSAIDS two days before (5 days for long-acting
NSAIDs), the day of, and 2 days following administration of Pemetrexed.

14. The patient has EGFR wild type.

Exclusion Criteria:

1. The patient has received prior definitive therapy (chemotherapy, surgery, or
radiotherapy) within 3 months of initiating study drug or within, 2 weeks of
localized palliative radiotherapy. Patients treated with initial biologic therapy
that progress are eligible (no drug within 4 weeks). Patients must have recovered
from the acute toxic effects prior to Day 1 of Cycle 1 to grade
2. Patients may not have had prior biologic therapy with antibodies targeting VEGF, EGFR
or IGFR.

3. The patient has undergone prior thoracic or abdominal surgery within 30 days of study
entry, excluding prior diagnostic biopsy.

4. The patient has a history of uncontrolled angina, arrhythmias, or congestive heart
failure.

5. The patient has inadequately controlled hypertension (defined as systolic blood
pressure > 140 and/or diastolic > 90 mm Hg on antihypertensive medications).

6. The patient has a history of stroke or transient ischemic attack within 6 months
prior to Day 1 of Cycle 1.

7. The patient is unable or unwilling to take folic acid, vitamin B12 supplementation,
or dexamethasone according to protocol.

8. The patient has neuropathy >/= grade 2.

9. The patient has a history of gastrointestinal fistula, perforation, or abscess,
inflammatory bowel disease, or diverticulitis.

10. The patient is currently receiving ongoing treatment with full-dose warfarin or
equivalent (that is, unfractionated and/or low molecular weight heparin).

11. The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.

12. Presence of significant third space fluid which cannot be controlled by drainage.

13. Patients are excluded from the Bevacizumab arm if they have a history of hemoptysis
(>/= ½ teaspoon of bright red blood per episode) within 3 months prior to
randomization. Patients are excluded from the IMC-A12 containing arm if they have
poorly controlled diabetes: HBA1C>8% or if the patient has abnormally elevated
fasting serum glucose (defined >110% ULN). Patients are excluded if they have known
hypersensitivity to any of the drugs.

14. The patient's tumor harbors the EML4-ALK fusion gene.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

42 days

Safety Issue:

Yes

Principal Investigator

John Heymach, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2010-0097

NCT ID:

NCT01263782

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • NSCLL
  • Nonsquamous cell
  • Metastatic disease
  • Cixutumumab
  • IMC-A12
  • Cetuximab
  • C225
  • Erbitux
  • IMC-C225
  • Carboplatin
  • Paraplatin
  • Pemetrexed
  • LY231514
  • Alimta
  • MTA
  • Multitargeted Antifolate
  • NSC-698037
  • Bevacizumab
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030