Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in refractory and relapsed pediatric solid tumors - ITCC-004-GEMOX

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 156

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 ³ 70% or ECOG performance status = 1 • Life expectancy ³ 3 months• Adequate organ function:Adequate hematological function: neutrophil count ³ 1.0 x 109/L, platelet count ³ 100 x 109/L; in case of bone marrow disease: ³ 75 x 109/L; hemoglobin ³ 8 g/dLAdequate 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 m2Adequate hepatic function: bilirubin £ 1.5 x ULN; ASAT and ALAT £ 2.5 x ULN (ASAT, ALAT =5xULN 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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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-CNS tumors

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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