Phase 2
N=75
Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00193427 ↗Enrolled (actual)
75
Serious AEs
52.0%
Results posted
Nov 2012
Primary outcome: Primary: Pathologic Complete Response Rate — 0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Docetaxel (Drug); Gemcitabine (Drug); Carboplatin (Drug); Radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response Rate |
— | — |
| SECONDARY Progression Free Survival (PFS) |
9.9 | — |
| SECONDARY Overall Response Rate (ORR) |
30 | — |
| SECONDARY Overall Survival (OS) |
18 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00193427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.