Clinical trial NCT00315185: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Advanced Non-small Cell Lung Cancer
First Line Treatment
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2006-04-18
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: To determine the response rate and stable disease rate with this combination regimen
Secondary outcomes:
measure: To determine the clinical benefit (complete response [CR] + partial response [PR] + static disease [SD])
measure: Time to progression
measure: Survival rate
measure: As well as toxicity evaluation
Other outcomes:
Locations:
city: Drexel Hill
country: United States
facility: Consultants in Medical Oncology & Hematology Inc.
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Corey Langer, MD
role: PRINCIPAL_INVESTIGATOR
References: