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

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: Docetaxel
Drug: Gemcitabine
Drug: Carboplatin
Radiation: Radiation

Registration Number: NCT00193427

Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary: 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.

Detailed 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Radiation	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
Intervention	Docetaxel	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
Intervention	Gemcitabine	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
Intervention	Carboplatin	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

Primary Outcome Measures

Name	Time	Method
Pathologic Complete Response Rate	18 months	A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	19 months	Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause.
Overall Response Rate (ORR)	18 months	Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
Overall Survival (OS)	18 months	Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.