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

NCT00315185 | Completed Phase 2 DMC

• 1 other identifier: OPN-TH-017
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Advanced Non-small Cell Lung Cancer; First Line Treatment

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• To determine the clinical benefit (complete response [CR] + partial response [PR] + static disease [SD])

• Time to progression

• Survival rate

• As well as toxicity evaluation

Interventions

Cetuximab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Consultants in Medical Oncology & Hematology Inc.

Drexel Hill, Pennsylvania, 19026, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Corey Langer, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2006
• First Posted: April 18, 2006
• Study Start: December 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2008
• Last Updated: September 23, 2010

Record last verified: 2010-09

Locations

US (1)