Clinical trial NCT00193427: Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
Official title: Phase II Trial of Preoperative (Neo-adjuvant) Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
name: Eli Lilly and Company
First posted: 2005-09-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Pathologic Complete Response Rate
timeFrame: 18 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 19 months
measure: Overall Response Rate (ORR)
timeFrame: 18 months
measure: Overall Survival (OS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: David R. Spigel, MD
role: PRINCIPAL_INVESTIGATOR
References: