Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors

NCT00127049 | Unknown Phase 2

• 1 other identifier: GIP-TG
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Germ Cell Tumor

Keywords

Patients with relapsed non-seminomatous germ-cell tumors (NSGCT)

Outcome Measures

Primary Outcomes (1)

• Complete response rate

Secondary Outcomes (3)

• Toxicity

• Progression free survival

• Overall survival

Interventions

gemcitabine, ifosfamide, cisplatin, G-CSF DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed informed consent.

You may not qualify if:

• Patients infected by the human immunodeficiency virus (HIV)

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

Related Publications (1)

• Fizazi K, Gravis G, Flechon A, Geoffrois L, Chevreau C, Laguerre B, Delva R, Eymard JC, Rolland F, Houede N, Laplanche A, Burcoveanu D, Culine S. Combining gemcitabine, cisplatin, and ifosfamide (GIP) is active in patients with relapsed metastatic germ-cell tumors (GCT): a prospective multicenter GETUG phase II trial. Ann Oncol. 2014 May;25(5):987-91. doi: 10.1093/annonc/mdu099. Epub 2014 Mar 4.

  PMID: 24595454 DERIVED

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Interventions

Gemcitabine; Ifosfamide; Cisplatin; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Karim FIZAZI, Dr

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karim FIZAZI, Dr

CONTACT

33 1 42114559; fizazi@igr.fr

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: August 3, 2005
• First Posted: August 5, 2005
• Study Start: December 1, 2004
• Last Updated: September 8, 2006

Record last verified: 2006-09

Locations

FR (1)