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
  Purpose

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.


Condition Intervention Phase
Germ Cell Tumor
Drug: Cisplatin plus Epirubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Cisplatin Plus Epirubicin Salvage Chemotherapy in Refractory Germ Cell Tumors

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • To determine the feasibility and toxicity of combining epirubicin to fixed dose cisplatin

Secondary Outcome Measures:
  • To determine the partial and complete response rate and duration of remission

Estimated Enrollment: 37
Study Start Date: October 2000
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </=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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198172

Locations
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Indiana University
Investigators
Principal Investigator: Lawrence Einhorn, M.D. Indiana University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00198172     History of Changes
Other Study ID Numbers: 0008-02
Study First Received: September 8, 2005
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Germ Cell Tumor
Refractory Germ Cell Tumors
Cisplatin plus Epirubicin Salvage Chemotherapy

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Epirubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 20, 2014