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

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Brief Title

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

Official Title

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

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. This regimen will be used in eligible patients after progression on ECOG Study
      E39897.
    

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

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 To determine the partial and complete response rate and duration of remission

Condition

Germ Cell Tumor

Intervention

Cisplatin plus Epirubicin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

37

Start Date

October 2000

Completion Date

March 2007


Eligibility 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 					

Gender

All

Ages

15 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lawrence Einhorn, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00198172

Organization ID

0008-02



Study Sponsor

Indiana University School of Medicine

Collaborators

 Indiana University

Study Sponsor

Lawrence Einhorn, M.D., Principal Investigator, Indiana University


Verification Date

May 2014