Status:
TERMINATED
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Indiana University
Conditions:
Germ Cell Tumor
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief Summary
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. T...
Detailed Description
To determine the feasibility and toxicity of combining epirubicin to fixed does cisplatin; to determine the partial and complete response rate and duration of remission; to determine the toxicity; to ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00198172
Start Date
October 1 2000
End Date
March 1 2007
Last Update
June 3 2014
Active Locations (1)
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1
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202