Study of Paclitaxel, Carboplatin, and Cetuximab for Advanced Lung Cancer

September 22, 2010 updated by: Fox Chase Cancer Center

Phase II Study as First Line Treatment for Patients With Advanced Non-Small Cell Lung Cancer

The purpose of this study is to determine the role of cetuximab (Erbitux) with chemotherapy for advanced colorectal carcinoma. This study will determine if this new agent can improve one's response to standard treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research study is being done to determine if cetuximab will improve efficacy of standard chemotherapy. This agent targets epidermal growth factor receptor (EGFR). EGFR sits on the outside of tumor cells and controls tumor cell growth. This agent has been looked at alone and with other chemotherapy drugs in non-small-cell lung cancer (NSCLC). It has shown to be safe and can shrink tumors. There is little information about the combination of this agent with both paclitaxel and carboplatin. This study combines cetuximab with monthly carboplatin and weekly paclitaxel.

Study Type

Interventional

Enrollment (Actual)

53

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
    • Pennsylvania
      • Drexel Hill, Pennsylvania, United States, 19026
        • Consultants in Medical Oncology & Hematology Inc.

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:

  • Histologically or cytologically documented stage IIIB or IV NSCLC
  • Measurable disease
  • ECOG performance status of 0-1
  • Asymptomatic brain metastasis; must have completed radiotherapy/radiosurgery at least 2 weeks prior to enrollment and be off steroids.
  • Radiotherapy must have been completed > 2 weeks prior to enrollment and patients must have recovered from adverse events of radiotherapy.
  • >/= 18 years of age
  • Adequate hematologic function: absolute neutrophil count (ANC) >/= 1,500/mm3; platelets >/= 100,000/mm3.
  • Adequate hepatic function: total bilirubin </= 1.5 X upper limit of normal (ULN); AST and ALT </= 2.5 X ULN.
  • Adequate renal function: serum creatinine </= 1.5mg/dL or creatinine clearance >/= 50cc/minute if serum creatinine > 1.5
  • Signed an approved informed consent for this protocol and an approved informed consent for Health Insurance Portability and Accountability Act (HIPAA)
  • EGFR status by immunohistochemistry (IHC) if sufficient tissue is available

Exclusion Criteria:

  • Women of childbearing potential who have a positive pregnancy test at enrollment or within 7 days of treatment. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth regulation/control. Note: Patients are considered to not be of childbearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
  • Patients 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 patient has been disease-free for 3 years.
  • Patients with significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, myocardial infarction within the past year, cardiomyopathy with decreased ejection fraction, or cardiac ventricular arrythmias within the last year requiring new treatment .
  • Patients with an uncontrolled seizure disorder, or active neurological disease.
  • Patients with symptomatic brain metastasis.
  • Patients who have received prior systemic chemotherapy.
  • Patients who have received prior cetuximab or other therapy which specifically and directly targets the EGF pathway.
  • Prior infusion reaction to a monoclonal antibody or prior hypersensitivity to Cremophor EL.
  • Patients with known peripheral neuropathy (> grade 1).

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the response rate and stable disease rate with this combination regimen

Secondary Outcome Measures

Outcome Measure
Time to progression
Survival rate
To determine the clinical benefit (complete response [CR] + partial response [PR] + static disease [SD])
As well as toxicity evaluation

Collaborators and Investigators

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

Sponsor

Fox Chase Cancer Center

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, 2004

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

April 14, 2006

First Submitted That Met QC Criteria

April 17, 2006

First Posted (ESTIMATE)

April 18, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2010

Last Update Submitted That Met QC Criteria

September 22, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPN-TH-017

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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