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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00193427
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 13, 2012
Last Update Posted : March 3, 2022
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Docetaxel Drug: Gemcitabine Drug: Carboplatin Radiation: Radiation Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2004
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
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
30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles
Other Name: Taxotere

Drug: Gemcitabine
1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles
Other Name: Gemzar

Drug: Carboplatin
AUC = 1.5 weekly x 7
Other Name: Paraplatin

Radiation: Radiation
To 63 Gy


Outcome Measures
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Primary Outcome Measures :
  1. Pathologic Complete Response Rate [ Time Frame: 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 :
  1. Progression Free Survival (PFS) [ Time Frame: 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.

  2. Overall Response Rate (ORR) [ Time Frame: 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.

  3. Overall Survival (OS) [ Time Frame: 18 months ]
    Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193427


Locations
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United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Aventis Pharmaceuticals
Eli Lilly and Company
Investigators
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Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
More Information
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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193427    
Other Study ID Numbers: SCRI LUN 76
First Posted: September 19, 2005    Key Record Dates
Results First Posted: November 13, 2012
Last Update Posted: March 3, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Carboplatin
Docetaxel
Antineoplastic Agents
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators