Clinical trial · Interventional
Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma
NCT00050674CI-TRIAL-00008747completedPhase 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)
Determine whether patients have a decreased incidence of grade 3 and grade 4 neutropenia when Filgrastim-SD/01 is given with docetaxel and gemcitabine in patients with advanced 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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Filgrastim-SD/01 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Filgrastim-SD/01
- description
- 6 mg SC, Day 9, 24 hours after the end of the chemotherapy infusion
- interventionNames
- Drug: Filgrastim-SD/01
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Histologically or cytologically documented non-small cell lung cancer * Subjects must have stage IV or IIIB NSCLC * 0-1 prior treatment regimens of chemotherapy * Subjects must have bi-dimensionally measurable disease or evaluable disease by physical exam or radiological studies * Age \> 18 years * 1st Line - ECOG 0-2 * 2nd Line - ECOG 0-1 * Absolute neutrophil count \> or = 1.5 x 10 to the 9th power/L * Platelet count \> or = 100 x 10 to the 9th power/L * Adequate renal function with screening serum creatinine \< or = 2.0 mg/dL * Adequate AST and ALT no more than 1.5 x the upper limit of normal and serum bilirubin \< or = upper limit of normal * Subjects must be at least two weeks from prior major thoracic or abdominal surgery and at least two weeks from completion of radiation therapy, and recovered from all toxicities associated with these treatments * Negative HCG by urine or blood test in subject of child-bearing potential * Life expectancy \> 2 months * Ethical - Before any study specific procedure is done or before study medication is administered, the subject or legally acceptable representative must give informed consent for participation in the study
References
Publications (0)
Data not yet available
No reference posted for this study.