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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193427
• Other study ID #: SCRI LUN 76
• Status: Completed
• Phase: Phase 2
• Start date: April 2004
• Est. completion date: December 2008

Study information

• Verified date: February 2022
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Docetaxel
30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles
• Gemcitabine
1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles
• Carboplatin
AUC = 1.5 weekly x 7

Radiation:
• Radiation
To 63 Gy

Locations

Country	Name	City	State
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Aventis Pharmaceuticals, Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months
Secondary	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.	19 months
Secondary	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.	18 months
Secondary	Overall Survival (OS)	Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.	18 months