Clinical trial · Interventional
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemotherapy in Refractory Germ Cell Tumors
NCT00198172CI-TRIAL-00014765terminatedPhase 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): Accrual Goal Met
Summary
Brief summary (as posted)
This study proposes to evaluate the combination of cisplatin plus epirubicin in patients with refractory germ cell tumor not amendable to cure with surgery or standard platinum salvage chemotherapy. This regimen will be used in eligible patients after progression on ECOG Study E39897.
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 |
|---|---|---|---|
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin plus Epirubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the feasibility and toxicity of combining epirubicin to fixed dose cisplatin
Secondary outcomes (1)
- measure
- To determine the partial and complete response rate and duration of remission
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * histologic or serologic proof of metastatic germ cell neoplasm(gonadal or extragonadal primary) w/ disease not amenable to cure with either surgery or chemotherapy. Pts w/ seminoma \& non-seminoma are eligible, as are women w/ ovarian germ cell tumors. * Must have failed initial cisplatin combination therapy administered w/ curative intent. In addition, pts should have failed and demonstrated progressive disease following the administration of at least one "salvage" regimen for advanced germ cell neoplasms unless they have primary mediastinal nonseminomatous germ cell tumor, or are considered to be a late relapse (\>2 yrs since becoming a complete response). * Pts must have adequate system function (WBC\>/= 4,000 \& plts \>/=100,000; SGOT \</=4x normal; bilirubin \</=2.0; serum crt \</=2.5) obtained \</= 4 wks prior to entry. * ECOG performance status of 0,1, or 2. * Pts must be at least 3 weeks post major surgery, radiotherapy, or chemotherapy, and have recovered from all toxicity. * Exclusion Criteria: * Active, unresolved infection and/or are receiving concurrent treatment w/ parenteral antibiotics. \*Eligible after antibiotics have been discontinued for at least 7 days. * Pregnant or lactating * Progression w/in 4 wks of lst course of cisplatin combination chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.