AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 2NCT00828841

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

A Phase 2 study testing Cetuximab, Paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer, run by Accelerated Community Oncology Research Network at 84 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Cetuximab, Paclitaxel and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
601 participants
Where
84 sitesUnited States
Study dates
Dec 2008to Aug 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

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

84 sites in 1 country.

84 sites in 1 country

United States84 sites

  • Study site

    Anaheim, California

  • Study site

    Anniston, Alabama

  • Study site

    Arnes, Iowa

  • Study site

    Augusta, Georgia

  • Study site

    Azusa, California

  • Study site

    Baltimore, Maryland

  • Study site

    Beaumont, Texas

  • Study site

    Bellville, New Jersey

  • Study site

    Bend, Oregon

  • Study site

    Bennington, Vermont

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Bettendorf, Iowa

  • Study site

    Billings, Montana

  • Study site

    Bristol, Tennessee

  • Study site

    Burbank, California

  • Study site

    Campbell, California

  • Study site

    Chattanooga, Tennessee

  • Study site

    Cherry Hill, New Jersey

  • Study site

    Columbus, Georgia

  • Study site

    Columbus, Ohio

  • Study site

    Corpus Christi, Texas

  • Study site

    Dayton, Ohio

  • Study site

    East Setauket, New York

  • Study site

    Elizabeth, New Jersey

  • Study site

    Elmhurst, Illinois

  • Study site

    Fayetteville, North Carolina

  • Study site

    Fort Collins, Colorado

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fresh Meadows, New York

  • Study site

    Gastonia, North Carolina

  • Study site

    Goldsboro, North Carolina

  • Study site

    Grand Island, Nebraska

  • Study site

    Greenbrae, California

  • Study site

    Hackensack, New Jersey

  • Study site

    Harvey, Illinois

  • Study site

    Hawthorne, California

  • Study site

    Hazard, Kentucky

  • Study site

    Huntington, West Virginia

  • Study site

    Jefferson City, Missouri

  • Study site

    Joliet, Illinois

  • Study site

    Jonesboro, Arkansas

  • Study site

    Kirkland, Washington

  • Study site

    Lafayette, Louisiana

  • Study site

    Lake Worth, Florida

  • Study site

    Lawrenceville, Georgia

  • Study site

    Louisville, Kentucky

  • Study site

    Lubbock, Texas

  • Study site

    Marietta, Georgia

  • Study site

    Mason City, Iowa

  • Study site

    Memphis, Tennessee

  • Study site

    Middletown, Ohio

  • Study site

    Mission Hills, California

  • Study site

    Norwich, Connecticut

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Orange City, Florida

  • Study site

    Oxnard, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Portsmouth, New Hampshire

  • Study site

    Quincy, Illinois

  • Study site

    Reading, Pennsylvania

  • Study site

    Saint Joseph, Missouri

  • Study site

    Sandusky, Ohio

  • Study site

    Shreveport, Louisiana

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Skokie, Illinois

  • Study site

    South Bend, Indiana

  • Study site

    Springfield, Massachusetts

  • Study site

    St Louis, Missouri

  • Study site

    St. Helena, California

  • Study site

    St. Petersburg, Florida

  • Study site

    Sumter, South Carolina

  • Study site

    Tacoma, Washington

  • Study site

    The Bronx, New York

  • Study site

    Titusville, Florida

  • Study site

    Torrington, Connecticut

  • Study site

    Towson, Maryland

  • Study site

    Trumbull, Connecticut

  • Study site

    Valdosta, Georgia

  • Family Medicine of Vincennes

    Vincennes, Indiana

  • Study site

    Waterloo, Iowa

  • Study site

    Wauwatosa, Wisconsin

  • Study site

    Weston, Florida

  • Study site

    Worchester, Massachusetts

Other trials in United States

About this study

Official title: 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.

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • CetuximabDrug

    Also called Erbitux

    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.

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel 200 mg/m2 Day 1 every 21 days

  • CarboplatinDrug

    Also called Paraplatin

    Carboplatin AUC 6 Day 1 every 21 days

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days

  • CisplatinDrug

    Also called Platinol

    Cisplatin 75 mg/m2 Day I every 21 days

Study groups in NCT00828841
Study groupRoleWhat they receive
Paclitaxel, Carboplatin, Cetuximab (Arm A)Active comparatorPatients 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.
Receives: Drug: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin
Platinum, Gemcitabine, Cetuximab (Arm B)Active comparatorPatients 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.
Receives: Drug: Cetuximab; Drug: Carboplatin; Drug: Gemcitabine; Drug: Cisplatin
Platinum, Pemetrexed, Cetuximab (Arm C)Active comparatorPatients 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.
Receives: Drug: Cetuximab; Drug: Carboplatin; Drug: Cisplatin

What is being measured

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

  1. Overall Survival by Treatment Arm

    Measured: 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 outcomes (2)

  1. 1-year Survival by Treatment Arm

    Measured: 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.

  2. Overall Survival by Histology

    Measured: 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.

Timeline

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

  1. First posted26 Jan 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionJul 2012
  4. Study completionAug 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
601 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00828841
Sponsor's protocol ID
AC01L08
Status last verified
Oct 2013
First submitted
23 Jan 2009
Last updated
6 Nov 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab, Paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer, run by Accelerated Community Oncology Research Network at 84 sites 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 12 inclusion and 19 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 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites 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 Oct 2013). 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?

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.). 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 NCT00828841.

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 6 Nov 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in