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

NCT00193427 | Completed Phase 2 Results

• 1 other identifier: SCRI LUN 76
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression Free Survival (PFS)

  19 months

• Overall Response Rate (ORR)

  18 months

• Overall Survival (OS)

  18 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

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

Interventions

Docetaxel DRUG

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

Also known as: Taxotere

Intervention

Gemcitabine DRUG

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

Also known as: Gemzar

Intervention

Carboplatin DRUG

AUC = 1.5 weekly x 7

Also known as: Paraplatin

Intervention

Radiation RADIATION

To 63 Gy

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Aventis Pharmaceuticals: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Docetaxel; Gemcitabine; Carboplatin; Radiation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Physical Phenomena

Results Point of Contact

• Title: John Hainsworth, MD
• Organization: Sarah Cannon Research Institute

ASKSARAH@scresearch.net

1-877-691-7274

Study Officials

• David R. Spigel, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 3, 2022
• Results First Posted: November 13, 2012

Record last verified: 2022-02

Locations

US (1)