Clinical trial · Interventional
Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)
A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer
NCT00173888CI-TRIAL-00008620completedPhase 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)
The purpose of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and gemcitabine plus cisplatin followed by weekly docetaxel。
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel, Cisplatin | Drug | — | UNRESOLVED |
| Gemcitabine, Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Docetaxel, Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: Gemcitabine, Cisplatin
Primary outcomes (1)
- measure
- The primary objective of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens.
- timeFrame
- 2003~2009
Secondary outcomes (1)
- measure
- To evaluate the response rate for each regimen, the toxicity of each arm, and the duration of response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of stage IIIB/IV NSCLC, no prior chemotherapy * Age \> 18 years and \< 75 years * WHO PS: 0,1 * Unidimensional or bi-dimensional measurable disease * Neutrophils \> 1.5 109/l, Platelets \> 100 109/l, Hemoglobin \> 10g/dl, Total bilirubin \< 1.5 UNL, AST (SGOT) and ALT (SGPT) \< 2.5 UNL, Alkaline phosphatases \< 5 UNL; except in presence of only bone metastasis and in the absence of any liver disorders * Creatinine \< 1 UNL, and creatinine clearance should be \> 60 ml/min. * Life expectancy \> 12 weeks Exclusion Criteria: * Pregnant, or lactating patients * Known clinical brain or leptomeningeal involvement * Pre-existing motor or sensory neurotoxicity of a severity \> grade 1 by NCIC-CTG criteria * CHF, angina or arrhythmias * History of significant neurological or psychiatric disorders * Active uncontrolled infection * Contraindication for the use of corticosteroids * Concurrent treatment with other experimental drugs within 30 days prior to study entry * Concurrent treatment with any other anti-cancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.