Phase I trial of carboplatin in combination with irinotecan and paclitaxel split-dosed on days 1 and 8
Phase I study of the maximum dose tolerability of carboplatin-irinotecan-paclitaxel combination (CIP) in patients with advanced refractory solid tumours
Hellenic Cooperative Oncology Group
20 participants
Jun 28, 2002
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- Cardiovascular: myocardial infarction within 6 months. Current, uncontrolled cardiac arrhythmias. History of anaphylactic reactions. Pregnancy. Serious uncontrolled, concurrent medical disorders.
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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 benefit in the absence of dose limiting toxicity
Locations(1)
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ACTRN12609000790246