Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors
This study has been terminated.
(Accrual Goal Met)
Sponsor:
Indiana University School of Medicine
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00198172
First received: September 8, 2005
Last updated: April 3, 2007
Last verified: April 2007
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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 |
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
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
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: | April 3, 2007 |
| 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 May 16, 2013