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Clinical Trials/NCT00127049
NCT00127049
Unknown
Phase 2

A Prospective Multicenter Phase II Trial of Gemcitabine, Cisplatin, and Ifosfamide (GIP) in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors (NSGCT) and a Predicted Favorable Prognosis

Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country37 target enrollmentDecember 2004
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ConditionsGerm Cell Tumor
Drugsgemcitabine, ifosfamide, cisplatin, G-CSF

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Germ Cell Tumor
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Enrollment
37
Locations
1
Primary Endpoint
Complete response rate
Last Updated
19 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.

Registry
clinicaltrials.gov
Start Date
December 2004
End Date
TBD
Last Updated
19 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients older than 16 years
  • •Histologically-proven disseminated (non stage I) NSGCT, or diagnosis of NSGCT based on very elevated serum human chorionic gonadotropin (HCG) and/or alpha fetoprotein (AFP)
  • •Relapsed disease classified as good prognosis according to the Memorial Sloan-Kettering Cancer Center (MSKCC) classification criteria:
  • •Testicular primary site
  • •Prior treatment limited to one program (or 6 or fewer cycles of cisplatin)
  • •Either a complete response or a partial response with normal serum AFP and HCG
  • •Relapse documented by rising AFP and/or HCG or by a biopsy
  • •No previous carcinoma, except basal-cell carcinoma of the skin
  • •Adequate renal function: measured or calculated creatinine clearance\> 60 ml/min
  • •Absolute granulocyte count \>= 1,500/mm3, platelets \>= 100,000 mm3, bilirubin \< 1.5 fold the upper normal value

Exclusion Criteria

  • •Patients infected by the human immunodeficiency virus (HIV)
  • •Patients who do not fit inclusion criteria

Outcomes

Primary Outcomes

Complete response rate

Secondary Outcomes

  • Toxicity
  • Progression free survival
  • Overall survival

Study Sites (1)

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