Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors
Stopped early · Phase 2
Conditions studied: Germ Cell Tumor
In brief
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.
Key facts
- Study ID
- NCT00198172
- Run by
- Indiana University
- People needed
- 37
- Starts
- 2000-10-01
- Expected to finish
- 2007-03-01
- Last updated by the study team
- 2014-06-03
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- Indiana University Cancer Center — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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