Clinical trial · Interventional
Paclitaxel and Cisplatin for Thymic Neoplasm
A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma
NCT00818090CI-TRIAL-00010035terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): marginal statistical significance
Summary
Brief summary (as posted)
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thymic Carcinoma | Thymus Carcinoma | CURATED_BROADER | 0.80 |
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TP
- description
- paclitaxel and cisplatin every 3 weeks
- interventionNames
- Drug: paclitaxel and cisplatin
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 6 weeks, 12 weeks, 18 weeks
Secondary outcomes (4)
- measure
- toxicity
- timeFrame
- start of medication to 4 weeks since the last medication
- measure
- progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically confirmed invasive thymoma or thymic carcinoma * unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator) * no previous systemic treatment for invasive thymoma or thymic carcinoma * at least one measurable lesion by RECIST criteria * 18 years old or older * ECOG performance status 0, 1, 2 * adequate lab. findings neutrophil ≥ 1.5 x 10\^9/L platelet ≥ 75 x 10\^9/L hemoglobin ≥ 9.0 g/dL bilirubin ≤ 1.5 x upper normal limit AST, ALT ≤ 2.5 x upper normal limit Alkaline phosphatase ≤ 2.5 x upper normal limit (if liver metastasis, ≤ 5 x upper normal limit) serum creatinine ≤ 1.0 x upper normal limit if serum creatinine \> 1.0 x upper normal limit, creatinine clearance ≥ 60 mL/min * patient who agree to written, informed consent Exclusion Criteria: * other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection) * active bacterial infection * history of clinical trial with investigational drug within 30 days * radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted) * pregnant, or lactating women * patient with organ transplantation * peripheral neuropathy, grade 2 or greater * severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months active ulcer disease refractory to medication chronic obstructive lung disease requiring admission treatment within 1 year * uncontrolled seizure, cerebral nervous system disorder, psychiatric problem which decrease treatment compliance
References
Publications (0)
Data not yet available
No reference posted for this study.