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


Phase 2
15 Years
N/A
Not Enrolling
Both
Germ Cell Tumor

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Trial Information

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


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 ascertain the potential for greater than 12 month continuous disease-free
survival and, therefore, potential curability.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the feasibility and toxicity of combining epirubicin to fixed dose cisplatin

Principal Investigator

Lawrence Einhorn, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Institutional Review Board

Study ID:

0008-02

NCT ID:

NCT00198172

Start Date:

October 2000

Completion Date:

March 2007

Related Keywords:

  • Germ Cell Tumor
  • Germ Cell Tumor
  • Refractory Germ Cell Tumors
  • Cisplatin plus Epirubicin Salvage Chemotherapy
  • Neoplasms, Germ Cell and Embryonal

Name

Location
Indiana University Cancer Center Indianapolis, Indiana  46202-5265