Clinical Studies of Gemcitabine-Oxaliplatin

This study has been completed.
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00407433
First received: December 4, 2006
Last updated: August 6, 2009
Last verified: August 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Single-Arm Studies of Gemcitabine in Combination With Oxaliplatin Refractory and Relapsed Pediatric Solid Tumors

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Birgit Geoerger, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00407433     History of Changes
Other Study ID Numbers: IGR 1205, ITCC-004-GEMOX
Study First Received: December 4, 2006
Last Updated: August 6, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Medulloblastoma
Nervous System Neoplasms
Neuroblastoma
Osteosarcoma
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents

ClinicalTrials.gov processed this record on July 24, 2014