Overview

Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors

Status:
Terminated
Trial end date:
2007-03-01
Target enrollment:
0
Participant gender:
All
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. This regimen will be used in eligible patients after progression on ECOG Study E39897.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Indiana University School of Medicine
Collaborator:
Indiana University
Treatments:
Cisplatin
Epirubicin
Criteria
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 normal; bilirubin
- 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.