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

April 8, 2010 updated by: Eli Lilly and Company

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 1

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
    • Colorado
      • Denver, Colorado, United States, 80262
        • ImClone Investigational Site
    • Connecticut
      • Greenwich, Connecticut, United States, 06830
        • ImClone Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • ImClone Investigational Site

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:

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.
  • 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.

Exclusion Criteria:

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.
  • 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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
An 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.
Biological: cetuximab
400 mg/m2 i.v. over 120 minutes
Other Names:
  • Erbitux
Drug: paclitaxel
225 mg/m2, infusion
Other Names:
  • Taxol
Drug: carboplatin
30-minute AUC = 6, infusion.
Other Names:
  • Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the safety profile of cetuximab when used in combination with paclitaxel and carboplatin
Time Frame: 8 Weeks
8 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Antitumor activity
Time Frame: 8 Weeks
8 Weeks
Effect of cetuximab on the pharmacokinetics of paclitaxel and carboplatin
Time Frame: 8 Weeks
8 Weeks

Collaborators and Investigators

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

Sponsor

Eli Lilly and Company

Collaborators

University of Colorado, Denver
Indiana University
Greenwich Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2000

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

April 30, 2002

First Submitted That Met QC Criteria

April 30, 2002

First Posted (Estimate)

May 1, 2002

Study Record Updates

Last Update Posted (Estimate)

April 9, 2010

Last Update Submitted That Met QC Criteria

April 8, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP02-9932

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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