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

This study has been completed.
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193427
First received: September 12, 2005
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Lung Cancer
Drug: Docetaxel
Drug: Gemcitabine
Drug: Carboplatin
Radiation: Radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Pathologic Complete Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 19 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.


Enrollment: 76
Study Start Date: April 2004
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193427

Locations
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
Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193427     History of Changes
Other Study ID Numbers: SCRI LUN 76
Study First Received: September 12, 2005
Results First Received: October 11, 2012
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Docetaxel
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 23, 2014