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Carcinoma, Non-Small-Cell LungPhase 1/2NCT00034541

Study of Cetuximab in Combination With Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer

A Phase 1/2 study testing cetuximab, paclitaxel and carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 3 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 study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
cetuximab, paclitaxel and carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
3 sitesUnited States
Study dates
Dec 2000to May 2003
Phase
Phase 1/2
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

  • The following inclusion criteria must be met:
  • The patient has stage IV NSCLC with either present or prior histologic or pathologic confirmation of NSCLC
  • The patient has uni-dimensionally measurable stage IV NSCLC
  • The patient has chemotherapy-naive stage IV NSCLC. The patient may have recurrent disease if prior radiation therapy was received. Pathological confirmation of recurrence is required for disease within a radiation portal.
  • The patient's ECOG performance status is ≤ 2 at study entry.
  • The patient has immunohistochemical evidence of EGFr expression (≥1+). Patients who do not have tumor tissue available for EGFr testing will undergo a biopsy of an accessible tumor. EGFr expression must be confirmed prior to study entry.
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  • The patient has given signed informed consent.
  • The patient is 18 years of age or older.
  • The patient has adequate hematologic function, as defined by an absolute neutrophil (ANC)≥ 1,500/mL3 , a WBC count≥3,000/mL3, a platelet count ≥100,000/mL3, and a hemoglobin level ≥9g/dL.
  • The patient has adequate hepatic function as defined by a total bilirubin level ≤1.5 X the upper limit of normal (ULN) and an alkaline phosphatase, AST, and ALT level ≤2.5 X the ULN.
  • The patient has adequate renal function with a serum creatinine level ≤1.5 mg/dL or a creatinine clearance ≥60 cc/minute.
  • The patient is disease free from a previously treated malignancy, other than the disease under study, for greater than 3 years (patients with a history of a previous basal cell carcinoma of the skin or preinvasive carcinoma of the cervix will not be excluded).
  • The patient, if a woman, agrees to use effective contraception if childbearing potential exists. The patient, if a man, agrees to use effective contraception.

Who cannot join

  • The following ten exclusion criteria are for this study:
  • The patient has received prior cetuximab therapy.
  • The patient has disease amenable to curative surgery.
  • The patient has received prior chemotherapy for the disease under study.
  • The patient has received wide field radiation therapy within 4 weeks prior to the first infusion of cetuximab. The patient may have local irradiation for the management of tumor-related symptoms.
  • The patient has undergone major thoracic or abdominal surgery within 30 days (to allow for a full recovery)prior to the first infusion of cetuximab.
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  • The patient has a history of uncontrolled angina,arrhythmias, or congestive heart failure.
  • The patient has uncontrolled seizure disorder, active neurological disease (not tumor related), or grade ≥2 neuropathy (patients with meningeal or central nervous system [CNS] involvement by the tumor will be eligible).
  • The patient has a history of hypersensitivity to Cremophor EL.
  • The patient, if a woman, is pregnant (confirmed by serum BHCG) or breastfeeding.
  • The patient has received any investigation agents within 30 days of study entry.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • ImClone Investigational Site

    Denver, Colorado, 80262

  • ImClone Investigational Site

    Greenwich, Connecticut, 06830

  • ImClone Investigational Site

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Phase Ib/IIa Study of an Anti-Epidermal Growth Factor Receptor (EGFr) Antibody Cetuximab in Combination With Carboplatin-Paclitaxel in Patients With Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer

The study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for efficacy and safety throughout the duration of the study.

Read the detailed description

The study will enroll approximately 33 chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive 3-week cycles of therapy with the exception of the initial cycle where the patients will receive 4 cycles of therapy. Patients will be enrolled after EGFr expression is confirmed and the study inclusion and exclusion criteria are met. An initial dose of cetuximab will be administered prior to the initiation of chemotherapy. Thereafter, cetuximab will be infused weekly. On the first day of each cycle, a paclitaxel infusion will be administered post completion of the cetuximab infusion, immediately followed by a carboplatin infusion. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for a tumor response at the end of every two cycles of therapy and evaluated for safety throughout the study.

Keywords
cetuximab, epidermal growth factor receptor, antibody, non-small cell lung cancer, carboplatin, paclitaxel
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

    400 mg/m2 i.v. over 120 minutes

  • paclitaxelDrug

    Also called Taxol

    225 mg/m2, infusion

  • carboplatinDrug

    Also called Paraplatin

    30-minute AUC = 6, infusion.

Study groups in NCT00034541
Study groupRoleWhat they receive
1ExperimentalAn initial dose of cetuximab (400 mg/m2 i.v. over 120 minutes) will be administered 1 week prior to the initiation of chemotherapy. Thereafter, cetuximab will be infused weekly at maintenance doses of 250 mg/m2 (over 60 minutes). On the first day of each cycle (every 3 weeks) of therapy, a 3-hour paclitaxel (225 mg/m2) infusion will be administered 1-hour post completion of the cetuximab infusion, immediately followed by a 30-minute carboplatin (AUC=6) infusion.
Receives: Biological: cetuximab; Drug: paclitaxel; Drug: carboplatin

What is being measured

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

  1. Assess the safety profile of cetuximab when used in combination with paclitaxel and carboplatin

    Measured: 8 Weeks

Secondary outcomes (2)

  1. Antitumor activity

    Measured: 8 Weeks

  2. Effect of cetuximab on the pharmacokinetics of paclitaxel and carboplatin

    Measured: 8 Weeks

Timeline

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

  1. First posted1 May 2002 (estimated)
  2. Study startDec 2000
  3. Primary completionMay 2003
  4. Study completionMay 2003

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00034541
Sponsor's protocol ID
CP02-9932
Status last verified
Apr 2010
First submitted
30 Apr 2002
Last updated
9 Apr 2010
Results posted
No
Data monitoring committee
No

Publications

  • Thienelt CD, Bunn PA Jr, Hanna N, Rosenberg A, Needle MN, Long ME, Gustafson DL, Kelly K. Multicenter phase I/II study of cetuximab with paclitaxel and carboplatin in untreated patients with stage IV non-small-cell lung cancer. J Clin Oncol. 2005 Dec 1;23(34):8786-93. doi: 10.1200/JCO.2005.03.1997. Epub 2005 Oct 24.

    PubMed 16246975

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing cetuximab, paclitaxel and carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 3 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 13 inclusion and 11 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 3 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Assess the safety profile of cetuximab when used in combination with paclitaxel and carboplatin (time frame: 8 Weeks). 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 NCT00034541, which also lists 1 linked publication.

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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