Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC

October 11, 2013 updated by: Accelerated Community Oncology Research Network

A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux) in Combination With Platinum-Based Chemotherapy as First Line Treatment of Patients With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)

This study is testing the investigational drug, cetuximab, in combination with different chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug combinations looks most promising and should be tested further. The study will also look at what side effects may occur.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

601

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States
    • Arkansas
      • Jonesboro, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Azusa, California, United States
      • Burbank, California, United States
      • Campbell, California, United States
      • Greenbrae, California, United States
      • Hawthorne, California, United States
      • Mission Hills, California, United States
      • Orange, California, United States
      • Oxnard, California, United States
      • St. Helena, California, United States
    • Colorado
      • Fort Collins, Colorado, United States
    • Connecticut
      • Norwich, Connecticut, United States
      • Torrington, Connecticut, United States
      • Trumbull, Connecticut, United States
    • Florida
      • Fort Lauderdale, Florida, United States
      • Lake Worth, Florida, United States
      • Orange City, Florida, United States
      • Pembroke Pines, Florida, United States
      • St. Petersburg, Florida, United States
      • Titusville, Florida, United States
      • Weston, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
      • Columbus, Georgia, United States
      • Lawrenceville, Georgia, United States
      • Marietta, Georgia, United States
      • Valdosta, Georgia, United States
    • Illinois
      • Elmhurst, Illinois, United States
      • Harvey, Illinois, United States
      • Joliet, Illinois, United States
      • Quincy, Illinois, United States
      • Skokie, Illinois, United States
    • Indiana
      • South Bend, Indiana, United States
      • Vincennes, Indiana, United States
        • Family Medicine of Vincennes
    • Iowa
      • Arnes, Iowa, United States
      • Bettendorf, Iowa, United States
      • Mason City, Iowa, United States
      • Waterloo, Iowa, United States
    • Kentucky
      • Hazard, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Lafayette, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Towson, Maryland, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
      • Worchester, Massachusetts, United States
    • Missouri
      • Jefferson City, Missouri, United States
      • St. Joseph, Missouri, United States
      • St. Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
    • Nebraska
      • Grand Island, Nebraska, United States
      • Omaha, Nebraska, United States
    • New Hampshire
      • Portsmouth, New Hampshire, United States
    • New Jersey
      • Bellville, New Jersey, United States
      • Cherry Hill, New Jersey, United States
      • Elizabeth, New Jersey, United States
      • Hackensack, New Jersey, United States
    • New York
      • Bronx, New York, United States
      • East Setauket, New York, United States
      • Fresh Meadows, New York, United States
    • North Carolina
      • Fayetteville, North Carolina, United States
      • Gastonia, North Carolina, United States
      • Goldsboro, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
      • Dayton, Ohio, United States
      • Middletown, Ohio, United States
      • Sandusky, Ohio, United States
    • Oregon
      • Bend, Oregon, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Reading, Pennsylvania, United States
    • South Carolina
      • Sumter, South Carolina, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Chattanooga, Tennessee, United States
      • Memphis, Tennessee, United States
    • Texas
      • Beaumont, Texas, United States
      • Corpus Christi, Texas, United States
      • Lubbock, Texas, United States
    • Vermont
      • Bennington, Vermont, United States
    • Washington
      • Kirkland, Washington, United States
      • Tacoma, Washington, United States
    • West Virginia
      • Huntington, West Virginia, United States
    • Wisconsin
      • Wauwatosa, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent before study-related activities
  • Histologically or cytologically confirmed Stage IIIb with cytologically documented malignant pleural or pericardial effusion, Stage IV, or recurrent non-smal cell lung cancer (NSCLC) after resection or radiation for earlier stage disease
  • Measurable or evaluable disease (per modified Response Evaluation Criteria in Solid Tumors [RECIST] guidelines)
  • Male or female ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • White blood count ≥ 3 x 10(9)/L with neutrophils ≥ 1.5 x 10(9)/L, platelet count ≥ 100 x 10(9)/L, and hemoglobin ≥ 9.5 g/dL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver mets
  • Serum creatinine ≤ 1.25 x ULN
  • Recovery from prior surgery or radiation to Grade 1 or better toxicity
  • Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 wks after the study in such a manner that the risk of pregnancy is minimized
  • WOCBP must have a negative serum or urine pregnancy test within 72 hrs prior to the start of study medication or in accordance with local regulations, whichever is of shorter duration

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test during screening or prior to study drug administration
  • Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential
  • Prior chemo for advanced NSCLC; neoadjuvant or post-operative adjuvant chemo is allowed if completed at least 12 months before study entry
  • Previous exposure to epidermal growth factor receptor (EGFR)-targeted therapy. Prior treatment with monoclonal antibodies targeting receptors other than the EGFR, such as bevacizumab, is allowed if completed > 30 days prior to randomization
  • Treatment with any investigational agent(s) within 4 weeks prior to study entry
  • Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, biologic or targeted therapy) other than protocol therapy
  • Carcinoid, atypical carcinoid or small cell lung cancer
  • Symptomatic or uncontrolled mets in the central nervous system
  • Prior invasive malignancy requiring ongoing therapy within the past year
  • Active infection (infection requiring intravenous [IV] antibiotics), including active tuberculosis, known and declared HIV
  • Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current Grade 3 or 4 cardiovascular disorder despite treatment
  • Known allergic/hypersensitivity reaction to any of the components of study treatments
  • Peripheral neuropathy ≥ Grade 2, as assessed by Common Terminology Criteria for Adverse Events, version 3.0
  • History of significant neurologic or psychiatric disorders including but not limited to dementia, seizures, and bipolar disorder
  • Medical or psychological condition that would not permit the patient to complete the study or sign informed consent
  • Known drug abuse

Patients of all races and ethnic groups are eligible for this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paclitaxel, Carboplatin, Cetuximab (Arm A)
Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.
Drug: Cetuximab
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Other Names:
  • Erbitux
Drug: Paclitaxel
Paclitaxel 200 mg/m2 Day 1 every 21 days
Other Names:
  • Taxol
Drug: Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Other Names:
  • Paraplatin
Active Comparator: Platinum, Gemcitabine, Cetuximab (Arm B)
Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.
Drug: Cetuximab
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Other Names:
  • Erbitux
Drug: Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Other Names:
  • Paraplatin
Drug: Gemcitabine
Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Other Names:
  • Gemzar
Drug: Cisplatin
Cisplatin 75 mg/m2 Day I every 21 days
Other Names:
  • Platinol
Active Comparator: Platinum, Pemetrexed, Cetuximab (Arm C)
Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.
Drug: Cetuximab
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Other Names:
  • Erbitux
Drug: Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Other Names:
  • Paraplatin
Drug: Cisplatin
Cisplatin 75 mg/m2 Day I every 21 days
Other Names:
  • Platinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival by Treatment Arm
Time Frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

Secondary Outcome Measures

Outcome Measure
Time Frame
1-year Survival by Treatment Arm
Time Frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
Overall Survival by Histology
Time Frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Accelerated Community Oncology Research Network

Investigators

  • Study Chair: Lee Schwartzberg, MD, FACP, Accelerated Community Oncology Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimate)

January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

October 11, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC01L08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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