Clinical trial NCT00198172: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Germ Cell Tumor
Keywords: Germ Cell Tumor
Refractory Germ Cell Tumors
Cisplatin plus Epirubicin Salvage Chemotherapy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University
First posted: 2005-09-20
Enrollment: 37
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 \</=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.

Primary outcomes:
measure: To determine the feasibility and toxicity of combining epirubicin to fixed dose cisplatin
Secondary outcomes:
measure: To determine the partial and complete response rate and duration of remission
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Lawrence Einhorn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: