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

September 12, 2005
October 11, 2012
April 2004
November 2008   (final data collection date for primary outcome measure)
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.
Pathologic complete response rate
Complete list of historical versions of study NCT00193427 on ClinicalTrials.gov Archive Site
  • 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.
  • Secondary Outcomes:
  • Overall response rate
  • Overall tolerability and toxicity
  • Resectability rates
  • Time-to-progression
  • Overall survival
Not Provided
Not Provided
 
Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
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

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.

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

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • 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
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
Interventions:
  • Drug: Docetaxel
  • Drug: Gemcitabine
  • Drug: Carboplatin
  • Radiation: Radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
December 2008
November 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00193427
SCRI LUN 76
No
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
  • Aventis Pharmaceuticals
  • Eli Lilly and Company
Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP