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Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Stage IV Lung Cancer

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage IV Non-small Cell Lung Cancer

Intervention: Cetuximab in combination with Carboplatin/Gemcitabine (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Francisco Robert, M.D., Principal Investigator, Affiliation: University of Alabama at Birmingham

Summary

The objective is to evaluate the toxicity profile, response rate, and time to progression of Cetuximab administered in combination with either Carboplatin + Gemcitabine in patients with advanced non-small cell lung cancer with positive EGFr expression.

Clinical Details

Official title: Phase Ib, IIa Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Evaluate the tumor response of cetuximab in combination with gemcitabine and carboplatin in patients with EGFr positive, chemotherapy-naive, Stage IV non-small cell lung cancer.

Secondary outcome: Evaluate the response rate and time to disease progression

Detailed description: The primary objective of this study is to evaluate the safety profile of Cetuximab when used in combination with gemcitabine and carboplatin in patients with EGFr positive, chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC). Also, the study will determine the response rate in patients with EGFr positive chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC) treated with Cetuximab in combination with gemcitabine and carboplatin as well as determine the time to progression in patients with EGFr positive chemotherapy-naive, stage IV NSCLC treated with Cetuximab in combination with gemcitabine and carboplatin.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have a diagnosis of histologically/cytologically confirmed advanced non- small cell

lung cancer (NSCLC).

- Have uni-dimensionally measurable and/or evaluable advanced NSCLC.

- Have Stage IV or recurrent disease following radiation therapy.

- Have ECOG performance status of 0-1 or Karnofsky performance status of 80- 100 at

study entry.

- Have given signed informed consent.

- Be at least 18 years of age.

- Have ANC greater than or equal to 1,500/mm3, platelets greater than or equal to

100,000/mm3, WBC greater than or equal to 3,000 mm3, and hemoglobin greater than or equal to 9 g/dL.

- Have total bilirubin less than or equal to 1. 5 x upper limits of normal, Alk Phos,

AST and ALT less than or equal to 2. 5 x upper limits of normal.

- Have serum creatinine less than or equal to 1. 5 mg/dL, or calculated creatinine

clearance greater than or equal to 60 cc/minute.

- Be disease free from a previously treated malignancy for more than three years.

Patients with a history or a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix will not be excluded.

- Agree to use effective contraception if procreative potential exists.

- Must have positive EGFr expression (tumor tissue) by immunohistochemical assay.

Exclusion Criteria:

- Have received prior murine monoclonal antibody or Cetuximab therapy.

- Have disease amenable to curative surgery.

- Have received prior chemotherapy.

- Have received radiation therapy within 3 weeks prior to the first infusion of

Cetuximab.

- Have a history of clinically significant cardiac disease, serious arrhythmias, or

significant conduction abnormalities, in the judgment of the PI.

- Have uncontrolled seizure disorder, active neurological disease, or Grade 2 or higher

neuropathy.

- Be pregnant or breast-feeding.

- Have received any investigational agent(s) within 1 month of study entry.

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Additional Information

Starting date: June 2001
Last updated: June 25, 2010

Page last updated: August 20, 2015

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