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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Advanced Non-small Cell Lung Cancer, First Line Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Consultants in Medical Oncology & Hematology Inc.

Outcomes

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

Full Information

First Posted
April 14, 2006
Last Updated
September 22, 2010
Sponsor
Fox Chase Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00315185
Brief Title
Study of Paclitaxel, Carboplatin, and Cetuximab for Advanced Lung Cancer
Official Title
Phase II Study as First Line Treatment for Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fox Chase Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Advanced Non-small Cell Lung Cancer, First Line Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cetuximab
Primary Outcome Measure Information:
Title
To determine the response rate and stable disease rate with this combination regimen
Secondary Outcome Measure Information:
Title
To determine the clinical benefit (complete response [CR] + partial response [PR] + static disease [SD])
Title
Time to progression
Title
Survival rate
Title
As well as toxicity evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey Langer, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Consultants in Medical Oncology & Hematology Inc.
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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