Clinical Studies of Gemcitabine-Oxaliplatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00407433
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : August 7, 2009
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

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

Condition or disease Intervention/treatment Phase
Medulloblastoma Central Nervous System Tumors Neuroblastoma Osteosarcoma Drug: Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Single-Arm Studies of Gemcitabine in Combination With Oxaliplatin Refractory and Relapsed Pediatric Solid Tumors

Primary Outcome Measures :
  1. 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 :
  1. The secondary efficacy variables are the duration of response, the time to treatment failure, the time to progressive disease and the overall survival.
  2. Clinical and laboratory toxicities/symptomatology will be graded according to NCI-Common toxicity criteria AE v3.0

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Ages Eligible for Study:   6 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00407433

Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Birgit Geoerger, MD Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT00407433     History of Changes
Other Study ID Numbers: IGR 1205
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: August 2009

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Paediatric solid tumors
Other CNS tumors
Other miscellaneous solid non-CNS tumours

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Nervous System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors