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Non-small Cell Lung CancerPhase 2NCT00097227

Trial of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Cetuximab, Carboplatin and Paclitaxel in people with Non-small Cell Lung Cancer, run by Eli Lilly and Company at 20 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of the study is to determine if the combination of cetuximab, carboplatin and paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer (NSCLC). The safety of this combination will also be evaluated. 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, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
20 sitesUnited States
Study dates
Nov 2004to Apr 2007
Phase
Phase 2
Are there results?
None posted in the registry

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

  • To be eligible for the study, subjects must fulfill all of the following criteria and have a complete signed informed consent form.
  • Subjects must have signed an approved informed consent.
  • Subjects with histologically or cytologically documented stage IIIB (supraclavicular lymph node, high neck node, or pleural effusion involvement) or IV NSCLC. Disease must be newly diagnosed or recurrent at least 1 year post adjuvant therapy.
  • Subjects with measurable disease.
  • Subjects with ECOG performance status 0-1.
  • Subjects with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 2 weeks prior to enrollment and be off steroids.
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  • Radiotherapy must have been completed > 2 weeks prior to enrollment and the subject must have recovered from all adverse effects of prior radiotherapy. No previous irradiation to the only area of measurable disease. New lesions that developed in a previously irradiated area will be allowed.
  • If diagnostic tissue or slides are available for a subject, these must be submitted for testing of EGFR status.
  • Subjects ≥18 years of age.
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level >35mIU/mL]. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
  • Subjects with adequate hematologic function defined as: ANC ≥1,500/mm 3 ; WBC
  • ≥3,000/mm 3 ; platelets ≥100,000/mm 3 ; and hemoglobin ≥9 g/dL.
  • Subjects with adequate hepatic function defined as: total bilirubin ≤1.5 x upper limit of normal (ULN) or AST ≤2.5 x ULN.
  • Subjects with adequate renal function defined as a serum creatinine level ≤1.5 mg/dL or a creatinine clearance ≥60 cc/minute.

Who cannot join

  • Any of the following criteria will make the subject ineligible to participate in this study.
  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Subjects who are men must also agree to use effective contraception.
  • WOCBP using a prohibited contraceptive method.
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Subjects who have had prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.
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  • Subjects with significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction, myocardial infarction within the past year, or cardiac ventricular arrythmias requiring medication.
  • Subjects with an uncontrolled seizure disorder, or active neurological disease.
  • Subjects with symptomatic brain metastasis. Prohibited Therapies and/or Medications
  • Subjects who have received prior systemic chemotherapy. Subjects with no more than one prior adjuvant regimen for initially diagnosed disease are eligible for the study.
  • Subjects with a history of prior cetuximab or other therapy that specifically and directly targets the EGFR pathway.
  • Subject with prior severe infusion reaction to a monoclonal antibody.
  • Subjects with know allergy to Cremophor EL.
  • Subjects with known peripheral neuropathy (> grade 1).
  • Subjects with prior erythropoietin (i.e., Epogen, Procrit) treatment.
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • ImClone Investigational Site

    Baltimore, Maryland, 21204

  • ImClone Investigational Site

    Chapel Hill, North Carolina, 27599

  • ImClone Investigational Site

    Columbia, South Carolina, 29209

  • ImClone Investigational Site

    Houston, Texas, 77024

  • ImClone Investigational Site

    Knoxville, Tennessee, 37920

  • ImClone Investigational Site

    Los Angeles, California, 90089

  • ImClone Investigational Site

    Louisville, Kentucky, 40202

  • ImClone Investigational Site

    Morgantown, West Virginia, 26506

  • ImClone Investigational Site

    Newark, Delaware, 19713

  • ImClone Investigational Site

    Newark, New Jersey, 07112

  • ImClone Investigational Site

    Orlando, Florida, 32804

  • ImClone Investigational Site

    Philadelphia, Pennsylvania, 19141

  • ImClone Investigational Site

    Richmond, Virginia, 23230

  • ImClone Investigational Site

    Santa Monica, California, 90404

  • ImClone Investigational Site

    St. Petersburg, Florida, 33705

  • ImClone Investigational Site

    Tacoma, Washington, 98405

  • ImClone Investigational Site

    Temple, Texas, 76508

  • ImClone Investigational Site

    Terra Haute, Indiana, 47804

  • ImClone Investigational Site

    Tucker, Georgia, 30084

  • ImClone Investigational Site

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of Two Dose Schedules of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-small Cell Lung Cancer

The purpose of the study is to determine if the combination of cetuximab, carboplatin and paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer (NSCLC). The safety of this combination will also be evaluated.

Read the detailed description

Lung cancer is the second most common cancer diagnosed for both genders in the United States. Approximately 173,770 new cases are estimated for 2004. It is the leading cause of cancer deaths in both men and women, with approximately 160,440 deaths estimated for 2004. Prognosis for many is poor if not diagnosed at an early stage, and therapy for advanced disease is limited. The study will test two chemotherapy agents, carboplatin and paclitaxel, in combination with a newly approved drug called cetuximab, which is continuing to be tested in colorectal cancer and other cancers. Cetuximab is a monoclonal antibody, which is believed to work by attaching to an epidermal growth factor receptor (EGFR) on tumor cells and thereby blocking tumor cells from reproducing. It is an antibody to the EGFR. Fifty percent of lung cancers overexpress EGFR.

Rationale:

The present study is built upon the data from previous studies, incorporating cetuximab into each of two regimens of paclitaxel plus carboplatin. The results of prior studies using paclitaxel and carboplatin demonstrate that these drugs in combination, using a variety of schedules, are both safe and effective as therapy for advanced or metastatic NSCLC. The addition of biologic therapy with the anti-EGFR agent cetuximab to the combination will presumably maximize the therapeutic index while keeping toxicity to a minimum in patients with Stage IIIB/IV NSCLC.

Research Hypothesis:

Subjects with previously-untreated stage IIIB/IV NSCLC who receive a combination of paclitaxel, carboplatin, and cetuximab will have a progression-free survival rate greater than that previously reported for subjects receiving the combination of paclitaxel and carboplatin.

Keywords
NSCLC, non-small, lung, IIIb, IV, Carboplatin, Paclitaxel, Cetuximab, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
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.

  • CetuximabBiological

    Also called Erbitux

    (Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion.

    A cycle of therapy was defined as 3 weeks in Arm A and 4 weeks in Arm B.

  • CarboplatinDrug

    Also called Paraplatin

    (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.

  • PaclitaxelDrug

    Also called Taxol

    225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks. OR 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle.

Study groups in NCT00097227
Study groupRoleWhat they receive
Arm A (3-week cycle)Active comparatorCetuximab was administered weekly at an initial dose (Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. Paclitaxel 225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks. Carboplatin (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
Receives: Biological: Cetuximab; Drug: Carboplatin; Drug: Paclitaxel
Arm B (4-week cycle)Active comparatorCetuximab was administered weekly at an initial dose (Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. Paclitaxel 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle. Carboplatin (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.
Receives: Biological: Cetuximab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

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

  1. To estimate median progression free survival and the progression free survival rate

    Measured: 6 months

Secondary outcomes (5)

  1. To estimate the overall response rate in each treatment arm

    Measured: 6 months

  2. To estimate median survival and the survival rate at one year in each treatment arm

    Measured: 6 months

  3. To evaluate the toxicity profile of each treatment arm

    Measured: 6 months

  4. To explore the relationship between EGFR expression and the "clinical benefit" received from each treatment regimen

    Measured: 6 months

  5. To evaluate symptom response rate in each treatment arm using the Lung Cancer Subscale (LCS) of the FACT-L

    Measured: 6 months

Timeline

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

  1. First posted19 Nov 2004 (estimated)
  2. Study startNov 2004
  3. Primary completionApr 2007
  4. Study completionApr 2007

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
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00097227
Sponsor's protocol ID
CA225-058
Status last verified
Apr 2010
First submitted
18 Nov 2004
Last updated
9 Apr 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab, Carboplatin and Paclitaxel in people with Non-small Cell Lung Cancer, run by Eli Lilly and Company at 20 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 14 inclusion and 16 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 9 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To estimate median progression free survival and the progression free survival rate (time frame: 6 months). 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 NCT00097227.

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 9 Apr 2010.

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