Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Gemcitabine; Drug: Carboplatin; Drug: Docetaxel; Radiation: Radiation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193427

SCRI LUN 76

Details and patient eligibility

About

This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced NSCLC. This study will help to better define optimal preoperative regimens for patients with resectable NSCLC. Since both of these drugs are potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may produce not only radio-sensitization, but also considerable antitumor efficacy.

Full description

Upon determination of eligibility, patients will receive:

Pre-operative

• Docetaxel
• Gemcitabine Post-operative
• Docetaxel
• Carboplatin
• Radiation Therapy

Patients with stage IB and II NSCLC who achieved clear margins will not receive any further therapy. Patients with incomplete resection, resection margins of a T3 tumor that are positive or close, stage IIIA AND IIIB NSCLC or disease judged unresectable after preoperative chemotherapy will receive postoperative treatment

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• Histologically confirmed non-small cell lung cancer
• Must be operable candidate
• Clinical stage IB, II, and select III non-small cell lung cancer are eligible
• Measurable or evaluable disease
• Able to perform activities of daily living with minimal assistance
• Must be > 18 years of age
• Adequate bone marrow, liver or kidney
• No previous chemotherapy or radiation therapy for non-small cell lung cancer
• Moderate to severe peripheral neuropathy
• Understand the nature of this study and give written informed consent.

Exclusion criteria

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

• Stage IV disease
• History of prior malignancy within five years
• Women who are pregnant or breast-feeding

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Intervention

Experimental group

Description:

Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered

Treatment:

Radiation: Radiation

Drug: Docetaxel

Drug: Carboplatin

Drug: Gemcitabine