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

This study has been completed.
Sponsor:
Information provided by:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00315185
First received: April 14, 2006
Last updated: September 22, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study as First Line Treatment for Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • To determine the response rate and stable disease rate with this combination regimen

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

Enrollment: 53
Study Start Date: December 2004
Study Completion Date: June 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315185

Locations
United States, Pennsylvania
Consultants in Medical Oncology & Hematology Inc.
Drexel Hill, Pennsylvania, United States, 19026
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Corey Langer, MD Fox Chase Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00315185     History of Changes
Other Study ID Numbers: OPN-TH-017
Study First Received: April 14, 2006
Last Updated: September 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Fox Chase Cancer Center:
Advanced Non-small Cell Lung Cancer
First Line Treatment

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014