BATTLE-FL: Front-Line Biomarker-Integrated Treatment Study in Non Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech
ImClone LLC
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01263782
First received: December 17, 2010
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The goal of this clinical research study is to learn if knowing biomarker status can help researchers find better treatment combinations for patients with advanced NSCLC.

Researchers want to use biomarker status to decide what drug (bevacizumab, or cixutumumab) to give in combination with carboplatin and pemetrexed. The safety of these drug combinations will also be studied.


Condition Intervention Phase
Lung Cancer
Drug: Carboplatin
Drug: Pemetrexed
Drug: Bevacizumab
Drug: Cixutumumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BATTLE-FL: A Biomarker-Integrated Study in Patients With Advanced Non-Small Cell Lung Cancer Treated in the Front-Line (FL) Setting

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 225
Study Start Date: May 2011
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carboplatin + Pemetrexed

The chemotherapy will be Carboplatin (AUC 6) and Pemetrexed (500 mg/m2) every 3 weeks for 4 cycles.

Then maintenance Pemetrexed (500 mg/m2 every 3 weeks) will be administered until disease progression or excessive toxicity.

If patients are randomized into one of the arms with a biologic therapy, patients will take the chemotherapy prescribed above, but will also receive the biologic therapy during the same time period.

Drug: Carboplatin
AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles.
Other Name: Paraplatin
Drug: Pemetrexed
500 mg/m2 by vein on day 1 of each 21 day cycle.
Other Names:
  • LY231514
  • Alimta
  • MTA
  • Multitargeted Antifolate
  • NSC-698037
Experimental: Chemo (Carbo/Peme) + Bevacizumab
Carboplatin AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles. Pemetrexed 500 mg/m2 by vein on day 1 of each 21 day cycle. Bevacizumab 15 mg/kg by vein on day 1 of each 21 day cycle.
Drug: Carboplatin
AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles.
Other Name: Paraplatin
Drug: Pemetrexed
500 mg/m2 by vein on day 1 of each 21 day cycle.
Other Names:
  • LY231514
  • Alimta
  • MTA
  • Multitargeted Antifolate
  • NSC-698037
Drug: Bevacizumab
15 mg/kg by vein on day 1 of each 21 day cycle.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
Experimental: Chemo (Carbo/Peme)
Carboplatin AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles. Pemetrexed 500 mg/m2 by vein on day 1 of each 21 day cycle.
Drug: Carboplatin
AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles.
Other Name: Paraplatin
Drug: Pemetrexed
500 mg/m2 by vein on day 1 of each 21 day cycle.
Other Names:
  • LY231514
  • Alimta
  • MTA
  • Multitargeted Antifolate
  • NSC-698037
Experimental: Chemo (Carbo/Peme) + Cixutumumab

Carboplatin AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles. Pemetrexed 500 mg/m2 by vein on day 1 of each 21 day cycle.

Cixutumumab 20 mg/kg by vein on day 1 of each 21 day cycle.

Drug: Carboplatin
AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles.
Other Name: Paraplatin
Drug: Pemetrexed
500 mg/m2 by vein on day 1 of each 21 day cycle.
Other Names:
  • LY231514
  • Alimta
  • MTA
  • Multitargeted Antifolate
  • NSC-698037
Drug: Cixutumumab
20 mg/kg by vein on day 1 of each 21 day cycle.
Other Name: IMC-A12

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 </=2 at study entry.
  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 </= 2.5 X the upper limit of normal or </= 5.0 x ULN if liver metastases are 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 </= 1 or baseline.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263782

Contacts
Contact: John Heymach, MD, PHD 713-792-6363

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eli Lilly and Company
Genentech
ImClone LLC
Investigators
Principal Investigator: John Heymach, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01263782     History of Changes
Other Study ID Numbers: 2010-0097, NCI-2011-00301
Study First Received: December 17, 2010
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
NSCLL
Nonsquamous cell
Metastatic disease
Cixutumumab
IMC-A12
Carboplatin
Paraplatin
Pemetrexed
LY231514
Alimta
MTA
Multitargeted Antifolate
NSC-698037
Bevacizumab
Avastin
Anti-VEGF monoclonal antibody
rhuMAb-VEGF

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antibodies
Antibodies, Monoclonal
Folic Acid Antagonists
Pemetrexed
Bevacizumab
Carboplatin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014