CompletedPhase 1ACTRN12609000790246

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


Sponsor

Hellenic Cooperative Oncology Group

Enrollment

20 participants

Start Date

Jun 28, 2002

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a combination of three chemotherapy drugs (carboplatin, irinotecan, and paclitaxel) to find the best dosing schedule. It is for adults aged 18 to 75 with cancer who are in reasonably good physical condition and have adequate organ function.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 irinot

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)

Greece

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ACTRN12609000790246