Clinical trial · Interventional
Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Non-Small Cell Lung Cancer in Elderly Patients
A Randomized Phase III Comparison of Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Elderly or Poor Performance Status Patients With Advanced Non-Small Cell Lung Cancer
NCT00193323CI-TRIAL-00003605completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this randomized trial, we attempt to further define optimal palliative chemotherapy for elderly patients with advanced non-small cell lung cancer by comparing single agent treatment with weekly docetaxel versus combination therapy with weekly docetaxel plus gemcitabine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- median survival
- measure
- one-year survival.
Secondary outcomes (1)
- measure
- toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: To be included in this study, you must meet the following criteria: * Biopsy-proven non-small cell lung cancer * No previous chemotherapy. * Age \> 65 years * Age \< 65 years requires significant assistance to perform activities of daily * Stage IV disease or stage IIIB disease * Ability to perform activities of daily living with minimal assistance * Measurable or evaluable disease * Adequate bone marrow, liver and kidney * All patients must sign written informed consent prior to study entry. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: * Brain metastases * Meningeal metastases * Other uncontrolled malignancies * History of invasive cancer during the last 5 years * Moderate to severe peripheral neuropathy 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.
References
Publications (1)
- RESULTHainsworth JD, Spigel DR, Farley C, Shipley DL, Bearden JD, Gandhi J, Ann Houston G, Anthony Greco F. Weekly docetaxel versus docetaxel/gemcitabine in the treatment of elderly or poor performance status patients with advanced nonsmall cell lung cancer: a randomized phase 3 trial of the Minnie Pearl Cancer Research Network. Cancer. 2007 Nov 1;110(9):2027-34. doi: 10.1002/cncr.23019. PMID 17823908