Clinical trial · Interventional
Docetaxel and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Randomized Phase II Study of Docetaxel and Gemcitabine for Stage IIIB/IV Non-Small Cell Lung Cancer
NCT00003762CI-TRIAL-00022993completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel plus gemcitabine 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 |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I: docetaxel + gemcitabine
- description
- Patients receive docetaxel IV over 1 hour on day 1 followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
- interventionNames
- Drug: docetaxel
- Drug: gemcitabine hydrochloride
- type
- EXPERIMENTAL
- label
- Arm II: docetaxel + gemcitabine
- description
- Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB/IV nonsmall cell lung cancer eligible for first line chemotherapy Measurable disease (must be outside radiation port or proof of progressive disease) Metastatic CNS disease allowed if treated and stable for at least 21 days prior to study PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Absolute neutrophil count at least 1500/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: At least 3 months since prior myocardial infarction No uncontrolled congestive heart failure No uncontrolled arrhythmias Other: Not pregnant or nursing Fertile patients must use effective contraception Peripheral neuropathy less than grade 2 No history of hypersensitivity to products containing polysorbate 80 No other significant medical condition No meningeal carcinomatosis No weight loss of greater than 10% within past 3 months due to disease PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to pelvis, spine, or long bones and recovered No prior radiotherapy to at least 30% of bone marrow Surgery: Greater than 4 weeks since prior major surgery Other: At least 3 weeks since prior investigational drugs
References
Publications (2)
- BACKGROUNDHuschka MM, Mandrekar SJ, Schaefer PL, Jett JR, Sloan JA. A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials. Cancer. 2007 Feb 15;109(4):787-95. doi: 10.1002/cncr.22444. PMID 17211864
- BACKGROUNDJatoi A, Hillman S, Stella P, Green E, Adjei A, Nair S, Perez E, Amin B, Schild SE, Castillo R, Jett JR; North Central Cancer Treatment Group. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol. 2005 Dec 20;23(36):9113-9. doi: 10.1200/JCO.2005.03.7465. PMID 16361618