NCT00986674|CompletedPhase 2Results

Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer

Three-Arm Randomized Phase II Study of Carboplatin and Paclitaxel in Combination With Cetuximab, IMC-A12 or Both in Patients With Advanced Non-Small Cell Lung Cancer Who Will Not Receive Bevacizumab-Based Therapy

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2011-01976E4508U10CA021115

Study Type

interventional

Target

140

Locations

1 country

Sites

249

Timeline

RegisteredSep 2009

StartedSep 2009

CompletionDec 2013

Brief Summary

This randomized phase II trial is studying how well giving carboplatin and paclitaxel together with cetuximab and/or cixutumumab (IMC-A12) works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with monoclonal antibody therapy may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel are more effective when given with cetuximab and/or cixutumumab in treating non-small cell lung cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

140

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach

1 country

249 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

Study Start

First participant enrolled

September 1, 2009

Completed

28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed

10 months until next milestone

Results Posted

Study results publicly available

September 26, 2014

Completed

Last Updated

September 26, 2014

Status Verified

March 1, 2014

Enrollment Period

3.9 years

First QC Date

September 29, 2009

Results QC Date

September 19, 2014

Last Update Submit

September 19, 2014

Conditions

Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer

Keywords

Advanced Non-small Cell Lung CancerCarboplatinPaclitaxelCetuximabIMC-A12

Outcome Measures

Primary Outcomes (1)

Progression Free Survival
Progression free survival is defined as time from registration to disease progression or death from any cause, whichever occurred earlier. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions . All eligible and treated patients were included in the analysis.
Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3

Secondary Outcomes (2)

Overall Survival
assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3
Response Rate
Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3

Study Arms (3)

Arm I (carboplatin, paclitaxel, cetuximab)

EXPERIMENTAL

Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.

Drug: carboplatinDrug: paclitaxelBiological: cetuximab

Arm II (carboplatin, paclitaxel, cixutumumab)

EXPERIMENTAL

Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.

Biological: cixutumumabDrug: carboplatinDrug: paclitaxel

Arm III (carboplatin, paclitaxel, cetuximab, cixutumumab)

EXPERIMENTAL

Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.

Biological: cixutumumabDrug: carboplatinDrug: paclitaxelBiological: cetuximab

Interventions

cixutumumabBIOLOGICAL

Given IV

Also known as: anti-IGF-1R recombinant monoclonal antibody IMC-A12, IMC-A12

Arm II (carboplatin, paclitaxel, cixutumumab)Arm III (carboplatin, paclitaxel, cetuximab, cixutumumab)

carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Arm I (carboplatin, paclitaxel, cetuximab)Arm II (carboplatin, paclitaxel, cixutumumab)Arm III (carboplatin, paclitaxel, cetuximab, cixutumumab)

paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol

Arm I (carboplatin, paclitaxel, cetuximab)Arm II (carboplatin, paclitaxel, cixutumumab)Arm III (carboplatin, paclitaxel, cetuximab, cixutumumab)

cetuximabBIOLOGICAL

Given IV

Also known as: C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225

Arm I (carboplatin, paclitaxel, cetuximab)Arm III (carboplatin, paclitaxel, cetuximab, cixutumumab)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Stage IIIB disease
T4, NX with nodule in ipsilateral lung lobe allowed provided patient is not a candidate for combined chemotherapy and radiotherapy
Stage IV disease (includes M1a and M1b)
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Ineligible for or refused treatment with bevacizumab
No untreated or symptomatic central nervous system (CNS) metastases
Patients with a history of CNS metastases that are definitively treated, stable, and controlled are eligible provided the following criteria are met:
Definitive therapy (surgery and/or radiotherapy) has been administered
Not planning to undergo additional treatment for brain metastases
Clinically stable
Off corticosteroids or on a stable dose of corticosteroids for ≥ 14 days before study entry
ECOG performance status 0-1
Leukocytes \> 3,000/mm\^3
Absolute neutrophil count (ANC) \> 1,500/mm\^3
+20 more criteria

You may not qualify if:

Small cell lung cancer or mixed small cell and NSCLC
History of allergic reactions attributed to compounds of similar chemical or biological composition to cixutumumab
History of any medical or psychiatric condition, addictive disorder, or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study treatments or may interfere with the conduct of the study or interpretation of study results
Prior agents targeting the EGFR or Insulin-like growth factor (IGFR) pathways
Prior therapy for advanced NSCLC, except for surgery and/or radiotherapy
Prior systemic therapy, including bevacizumab for advanced stage NSCLC
Pregnant or nursing
Peripheral neuropathy \> grade 1 as per Common Terminology Criteria for Adverse Event (CTCAE) v 4.0
History of or suspected interstitial pneumonitis or pulmonary fibrosis on imaging
Significant uncontrolled cardiac disease within the past 6 months, including any of the following:
Uncontrolled hypertension (BP \> 150/100 mm Hg)
Unstable angina
Recent myocardial infarction
Uncontrolled congestive heart failure
Cardiomyopathy with decreased ejection fraction
+1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (249)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Exempla Saint Joseph Hospital

Denver, Colorado, 80218, United States

Location

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

Colorado Cancer Research Program CCOP

Denver, Colorado, 80224-2522, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81502, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Saint Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States

Location

North Suburban Medical Center

Thornton, Colorado, 80229, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Manchester Memorial Hospital

Manchester, Connecticut, 06040, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31208, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61701, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital Association

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

Evanston CCOP-NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Illinois CancerCare Galesburg

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Havana

Havana, Illinois, 62644, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, 60521, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Mcdonough District Hospital

Macomb, Illinois, 61455, United States

Location

Garneau, Stewart C MD (UIA Investigator)