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

NCT00198172 | Terminated Phase 2

• 1 other identifier: 0008-02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Germ Cell Tumor

Keywords

Germ Cell Tumor; Refractory Germ Cell Tumors; Cisplatin plus Epirubicin Salvage Chemotherapy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Cisplatin plus Epirubicin DRUG

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Indiana University: collaborator

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Interventions

Cisplatin; Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Lawrence Einhorn, M.D.

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 20, 2005
• Study Start: October 1, 2000
• Study Completion: March 1, 2007
• Last Updated: June 3, 2014

Record last verified: 2014-05

Locations

US (1)