None listed
Conditions
Brief summary
The primary objective of this trial is to determine the maximum-tolerated and recommended dosed of split-dosed irinotecan and paclitaxel when combined with carboplatin in patients with metastatic or recurrent refractory malignancies. Secondary objective was to evaluate the toxicity and safety of this combination regimen in this patient population and obtain preliminary data of activity. Cohorts of 3 to 6 patients will receive escalating doses of irinotecan and paclitaxel until the maximum tolerated dose is determined.
Interventions
This is a dose escalation study of irinotecan and paclitaxel given on days 1 and 8 in combination with carboplatin standard-dosed every three weeks. To investigate the maximum tolerated dose of irinotecan and pacitaxel split-dosed on days 1 and 8 in combination of carboplatin given in single effusion on day 1 before irinotecan and paclitaxel. n patients with solid tumors. Treatment will be recycled every three weeks and will continue to a maximum eight cycles in patients deriving clinical benefi
This is a dose escalation study of irinotecan and paclitaxel given on days 1 and 8 in combination with carboplatin standard-dosed every three weeks. To investigate the maximum tolerated dose of irinotecan and pacitaxel split-dosed on days 1 and 8 in combination of carboplatin given in single effusion on day 1 before irinotecan and paclitaxel. n patients with solid tumors. Treatment will be recycled every three weeks and will continue to a maximum eight cycles in patients deriving clinical benefit in the absence of dose limiting toxicity
Sponsors
Hellenic Cooperative Oncology Group
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Performance status: World Health Organization (WHO) 2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 3,000/mm3 Absolute lymphocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminase no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.4 mg/dL
Exclusion criteria
Cardiovascular: myocardial infarction within 6 months. Current, uncontrolled cardiac arrhythmias. History of anaphylactic reactions. Pregnancy. Serious uncontrolled, concurrent medical disorders.
Outcome results
None listed