Clinical trial · Interventional
Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas
A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma
NCT00134641CI-TRIAL-00001049completedPhase 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 determine if the combination of gemcitabine and vinorelbine is effective in treating patients with advanced soft tissue sarcoma.
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 |
|---|---|---|---|
| Sarcoma, Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma
Secondary outcomes (2)
- measure
- To determine the duration of response and the overall survival of patients with metastatic soft tissue sarcoma being treated with this combination
- measure
- to evaluate the safety of this combination in this patient population
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of unresectable or metastatic soft tissue sarcoma * Measurable disease outside of a prior irradiated area * ECOG performance status 0,1, or 2. * 0 or 1 prior regimens for advanced disease. * Adequate end organ function, defined as bilirubin \< 1.8; SGOT/SGPT \< 2.5 x upper limit of normal (ULN); creatinine \< 1.5 x ULN. * Negative pregnancy test * Life expectancy of greater than 3 months Exclusion Criteria: * Patient has received any investigational agents within 28 days of first day of study drug dosing * Two or more prior regimens for advanced disease * Prior gemcitabine or vinorelbine * Another primary malignancy * Grade III/IV cardia dysfunction * Female patients who are pregnant or breast-feeding * Severe and/or life-threatening medical disease * Known diagnosis of HIV infection * Prior chemotherapy within 4 weeks prior to study entry * Major surgery within 2 weeks prior to study entry * Known hypersensitivity to either gemcitabine or vinorelbine
References
Publications (0)
Data not yet available
No reference posted for this study.