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NCT Number: NCT00193427

Preoperative 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

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

Other names: Taxotere

Gemcitabine

Drug

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

Other names: Gemzar

carboplatin

Drug

AUC = 1.5 weekly x 7

Other names: Paraplatin

Radiation

Radiation

To 63 Gy

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Aventis Pharmaceuticals
  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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