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

This study has been terminated.
(Accrual Goal Met)
Sponsor:
Collaborator:
Indiana University
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00198172
First received: September 8, 2005
Last updated: May 30, 2014
Last verified: May 2014

September 8, 2005
May 30, 2014
October 2000
Not Provided
To determine the feasibility and toxicity of combining epirubicin to fixed dose cisplatin
Same as current
Complete list of historical versions of study NCT00198172 on ClinicalTrials.gov Archive Site
To determine the partial and complete response rate and duration of remission
Same as current
Not Provided
Not Provided
 
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemotherapy in Refractory Germ Cell Tumors

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Germ Cell Tumor
Drug: Cisplatin plus Epirubicin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
37
March 2007
Not Provided

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.
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00198172
0008-02
Not Provided
Not Provided
Indiana University School of Medicine
Indiana University
Principal Investigator: Lawrence Einhorn, M.D. Indiana University
Indiana University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP