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Clinical Studies of Gemcitabine-Oxaliplatin

This study is currently recruiting participants.
Verified by Institut Gustave Roussy, February 2007

Sponsored by: Institut Gustave Roussy
Information provided by: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT00407433
  Purpose

These are Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in refractory or relapsing pediatric solid tumors.


Condition Intervention Phase
Medulloblastoma
Central Nervous System Tumors
Neuroblastoma
Osteosarcoma
Drug: Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®)
Phase II

MedlinePlus related topics:   Cancer    Neuroblastoma   

ChemIDplus related topics:   Gemcitabine hydrochloride    Gemcitabine    Oxaliplatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase 2 Single-Arm Studies of Gemcitabine in Combination With Oxaliplatin Refractory and Relapsed Pediatric Solid Tumors

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • The primary endpoint for efficacy is the percentage of patients achieving complete or partial response according to WHO guidelines, after having received 4 cycles of gemcitabine-oxaliplatin (8 weeks).

Secondary Outcome Measures:
  • The secondary efficacy variables are the duration of response, the time to treatment failure, the time to progressive disease and the overall survival.
  • Clinical and laboratory toxicities/symptomatology will be graded according to NCI-Common toxicity criteria AE v3.0

Estimated Enrollment:   156

  Eligibility
Ages Eligible for Study:   6 Months to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed malignant solid tumor (at diagnosis)
  • Relapsed or refractory tumors in which correct standard treatment approaches have failed
  • Measurable primary and/or metastatic disease: at least one bi-dimensionally measurable lesion. For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993). For patients with osteosarcoma, measurable lesions are lung metastases and osseous lesions with soft tissue tumor, in exclusion of completely calcified or necrosed lesion at study entry. A patient with an unique osseous lesion without soft tissue mass can be included in the study if the lesion is operable and thus accessible for histological response assessment.
  • No more than one salvage therapy for relapse
  • Age at inclusion: 6 months to ≤ 20 years
  • Lansky play score ≥ 70% or ECOG performance status ≤ 1
  • Life expectancy ≥ 3 months
  • Adequate organ function:

    • Adequate hematological function: neutrophil count >= 1.0 x 10^9/L, platelet count >= 100 x 10^9/L; in case of bone marrow disease: >= 75 x 10^9/L; hemoglobin >= 8 g/dL
    • Adequate renal function: creatinine > 1.5 x ULN for age; If serum creatinine is > 1.5 ULN of age, then creatinine clearance (or radioisotope GFR) must be > 70 ml/min/1.73 m2 Adequate hepatic function: bilirubin > 1.5 x ULN; AST and ALT > 2.5 x ULN (AST, ALT ≤ 5 x ULN in case of liver metastases).
  • Wash out of 3 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 4 weeks in case of prior radiotherapy. Patients must have recovered from the acute toxic effects of all prior therapy before enrollment into the study.
  • Able to comply with scheduled follow-up and with management of toxicity
  • All patients with reproductive potential must practice an effective method of birth control while on study. Female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment.
  • Written informed consent from patient, parents or legal guardian

Exclusion Criteria:

  • Concurrent administration of any other antitumor therapy.
  • Have previously completed or withdrawn from this study or any other study investigating gemcitabine or oxaliplatin.
  • Have a serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient’s ability to complete the study
  • Pre-existing sensory or motor neuropathy >Grade 2 (excluding neuropathy due to disease and/or surgery)
  • History of allergic reaction to platinum compounds
  • Are pregnant or breast feeding
  • Presence of symptomatic brain metastases in patients with solid non-central nervous system (CNS) tumors
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407433

Contacts
Contact: Birgit Geoerger, MD     00 331 42 11 46 61     geoerger@igr.fr    
Contact: Marie Cécile Le Deley, MD     00 331 42 11 54 44     ledeley@igr.fr    

Locations
France
Institut Gustave Roussy     Recruiting
      Villejuif, France, 94800
      Contact: Birgit Geoerger, MD     00 331 42 11 46 61     geoerger@igr.fr    
      Contact: Marie Cécile Le Deley, MD     00 331 42 11 54 44     ledeley@igr.fr    

Sponsors and Collaborators
Institut Gustave Roussy

Investigators
Principal Investigator:     Birgit Geoerger, MD     Institut Gustave Roussy    
  More Information


Study ID Numbers:   IGR 1205, ITCC-004-GEMOX
First Received:   December 4, 2006
Last Updated:   July 18, 2007
ClinicalTrials.gov Identifier:   NCT00407433
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Gustave Roussy:
Gemcitabine  
Oxaliplatine  
Paediatric solid tumors  
Other CNS tumors  
Other miscellaneous solid non-CNS tumours  

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Osteosarcoma
Central Nervous System Neoplasms
Osteogenic sarcoma
Soft tissue sarcomas
Neuroblastoma
Neuroectodermal Tumors
Neoplasms, Connective and Soft Tissue
Oxaliplatin
Neoplasms, Germ Cell and Embryonal
Medulloblastoma
Sarcoma
Neuroepithelioma
Glioma
Gemcitabine
Nervous System Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Nervous System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Neoplasms, Bone Tissue
Radiation-Sensitizing Agents
Therapeutic Uses
Neoplasms, Connective Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on October 20, 2008




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