Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Gemcitabine; Drug: Cetuximab; Drug: Docetaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193453

SCRI LUN 92

Details and patient eligibility

About

This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.

Full description

Upon determination of eligibility all patients will receive:

• Docetaxel + Gemcitabine + Cetuximab

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

To be included in the study, you must meet the following criteria:

• 18 years of age or older
• Non-small cell lung cancer confirmed by biopsy
• Unresectable stage III or IV disease
• Measurable disease
• Must not have received any prior chemotherapy for lung cancer
• Able to perform activities of daily living without considerable assistance
• Adequate bone marrow, kidney, and liver function
• Signed informed consent

Exclusion criteria

You cannot participate in the study if any of the following apply to you:

• History of serious heart disease within six months prior to study entry
• Prior treatment with agents that target the EGFR pathway
• History of any other uncontrolled or significant disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Intervention

Experimental group

Description:

Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).

Treatment:

Drug: Cetuximab

Drug: Gemcitabine

Drug: Docetaxel