Clinical Studies of Gemcitabine-Oxaliplatin

NCT00407433 | Completed Phase 2

• 2 other identifiers: IGR 1205ITCC-004-GEMOX
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Medulloblastoma; Central Nervous System Tumors; Neuroblastoma; Osteosarcoma

Keywords

Gemcitabine; Oxaliplatine; Paediatric solid tumors; Other CNS tumors; Other miscellaneous solid non-CNS tumours

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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

Interventions

Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®) DRUG

Eligibility Criteria

• Age: 6 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Histologically or cytologically confirmed malignant solid tumor (at diagnosis)
• Relapsed or refractory tumors in which correct standard treatment approaches have failed
• No more than one salvage therapy for relapse
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Medulloblastoma; Central Nervous System Neoplasms; Neuroblastoma; Osteosarcoma

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

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; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Birgit Geoerger, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

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: December 4, 2006
• First Posted: December 5, 2006
• Last Updated: August 7, 2009

Record last verified: 2009-08

Locations

FR (1)