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Glivec Plus m-FOLFOX Avastin in Advanced Colorectal Cancer

ABSTRACT: This is a Phase I, dose finding, multicentre study evaluating the maximal tolerated dose of Glivec in combination with mFOLFOX-Avastin. Patients will be enrolled into each dose level in 3 patient cohorts. Additional cohorts will be enrolled, or dose levels opened, subject to the toxicities observed. Once the MTD has been determined the dose level below will be re-opened and extra patients, to a total of 15, will be enrolled.

DISEASE(S): Colorectal Neoplasms,Advanced Colorectal Cancer,Cancer

PROVIDER: 2100388 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Irinotecan (180mg/m2), and Panitumumab (6mg/Kg), will be administered intravenously (IV) on Day 1 of every 14 day cycle. Trifluridine/tipiracil will be administered orally (PO) twice a day (BD) on Days 1-5 of every 14 day cycle. Trifluridine/tipiracil will be supplied as 15 mg (comprising 15 mg trifluridine/6.14 mg tipiracil) and 20 mg (comprising 20 mg trifluridine/8.19mg tipiracil) immediate-release film-coated tablets and the number of tablets needed to achieve the assigned dose will be determined according to the patient’s body surface area. Dosing of trifluridine/tipiracil in the dose escalation phase (phase Ib) will be as follows: Dose LevelTrifluridine/tipiracil 1 (starting dose)25 mg/m2 orally, BD 2 30 mg/m2 orally, BD 3 35 mg/m2 orally, BD The dose escalation phase (phase Ib) will recruit participants who have received and failed one prior chemotherapy regimen for metastatic colorectal cancer (mCRC). It is anticipated that this phase of the study will take 6 months to complete. The maximum (MTD) will be assessed during the dose escalation phase, where participants will be enrolled in cohorts. Each cohort will consist of a minimum of 3 newly enrolled evaluable patients. If there is no dose-limiting toxicities (DLT) in the first 3 patients within a cohort, a new cohort at the next dose level will commence. If safety data show one patient in a cohort experiencing a DLT, then the cohort will be increased to a maximum of six evaluable patients. If no more than one of the six patients experiences a DLT, then the next dose level may be evaluated. If two or more patients entered in any cohort experience a DLT, then the MTD has been exceeded, and the previous dose level will be considered the MTD. If no dose level has 2 or more DLT`s, then dose level 3 will be considered the MTD. A minimum of 6 evaluable patients will be treated at the dose level before the dose can be declared as the MTD and enrolment into the phase II component can begin. Cohorts may also be expanded at any dose level to further assess safety parameters as required. If a dose level is opened and patients in the previous cohort subsequently develop unexpected toxicities the cohort will be closed and the previous cohort will be re-assessed with further patients enrolled into the previous cohort as required. The maximum tolerated dose (MTD) of tipiracil/trifluridine will be the dose level administered in the expansion phase (phase II). The expansion phase (phase II) will recruit participants that have received no prior treatment for mCRC, and is anticipated to take up to 18 months to complete. Treatment will continue until disease progression or withdrawal criteria are met.

Dataset Information

Glivec Plus m-FOLFOX Avastin in Advanced Colorectal Cancer

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