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

Germ Cell Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00198172
• Other study ID #: 0008-02
• Status: Terminated
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: May 30, 2014
• Start date: October 2000
• Est. completion date: March 2007

Study information

• Verified date: May 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal

Intervention

Drug:
• Cisplatin plus Epirubicin

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the feasibility and toxicity of combining epirubicin to fixed dose cisplatin
Secondary	To determine the partial and complete response rate and duration of remission