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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Docetaxel

Gemcitabine

Carboplatin

Radiation

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Tennessee Oncology, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm 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

Outcomes

Primary Outcome Measures

Pathologic Complete Response Rate

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

Progression Free Survival (PFS)

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)

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)

Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.

Full Information

NCT ID

NCT00193427

First Posted

September 12, 2005

Last Updated

February 21, 2022

Sponsor

SCRI Development Innovations, LLC

Collaborators

Aventis Pharmaceuticals, Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00193427

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SCRI Development Innovations, LLC

Collaborators

Aventis Pharmaceuticals, Eli Lilly and Company

4. Oversight

Data Monitoring Committee

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm 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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Paraplatin

Intervention Description

AUC = 1.5 weekly x 7

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

To 63 Gy

Primary Outcome Measure Information:

Title

Pathologic Complete Response Rate

Description

A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

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.

Time Frame

19 months

Title

Overall Response Rate (ORR)

Description

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.

Time Frame

18 months

Title

Overall Survival (OS)

Description

Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David R. Spigel, MD

Organizational Affiliation

SCRI Development Innovations, LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tennessee Oncology, PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37023

Country

United States

Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial