Clinical trial · Interventional
Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
NCT00022022CI-TRIAL-00013052unknownPhase 3ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
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 |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Quality of life
- measure
- Toxicity
- measure
- Response rate
- measure
- Time to progression
- measure
- Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC) * Metastatic supraclavicular lymphadenopathy or malignant pleural effusion * Progressive disease * Must have received prior chemotherapy * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and ALT no greater than 1.25 times ULN Renal: * Creatinine no greater than 1.25 times ULN Cardiovascular: * No prior or concurrent cardiovascular disease that would preclude study Pulmonary: * See Disease Characteristics * No prior or concurrent pulmonary disease that would preclude study Other: * No prior or other concurrent illness or medical condition that would preclude study * No other prior malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No prior docetaxel * At least 3 weeks since other prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy allowed * No concurrent radiotherapy Surgery: * Prior radical surgery for NSCLC allowed * Concurrent palliative surgery allowed
References
Publications (2)
- BACKGROUNDDi Maio M, Perrone F, Chiodini P, Gallo C, Camps C, Schuette W, Quoix E, Tsai CM, Gridelli C. Individual patient data meta-analysis of docetaxel administered once every 3 weeks compared with once every week second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2007 Apr 10;25(11):1377-82. doi: 10.1200/JCO.2006.09.8251. PMID 17416857
- RESULTGridelli C, Gallo C, Di Maio M, Barletta E, Illiano A, Maione P, Salvagni S, Piantedosi FV, Palazzolo G, Caffo O, Ceribelli A, Falcone A, Mazzanti P, Brancaccio L, Capuano MA, Isa L, Barbera S, Perrone F. A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study. Br J Cancer. 2004 Dec 13;91(12):1996-2004. doi: 10.1038/sj.bjc.6602241. PMID 15558071