Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

Официальное название

Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

Обзор

This study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.

Подробное описание

This prospective phase II, single arm, single site trial will evaluate the efficacy of the combination of liposomal irinotecan (nal-IRI), TAS102, and bevacizumab for the treatment of patients with mismatch repair proficient, metastatic or unresectable colorectal cancer that has previously been treated with 5-fluorouracil, oxaliplatin, irinotecan and if RAS wild-type an anti-EGFR agent. A total of 25 patients will be accrued at UW Carbone Cancer Center. Subject enrollment will occur over 12 months with the total duration of the trial expected to be 3 years.

Primary Objective

* To determine the progression free survival (PFS) of patients with metastatic colorectal cancer treated in the treatment refractory setting with liposomal irinotecan in combination with TAS102 and bevacizumab.

Secondary Objectives

* To evaluate the objective response rate (ORR) of liposomal irinotecan in combination with bevacizumab and TAS102. * To assess the safety and tolerability of these regimens in this setting. * To determine the impact of the timing of irinotecan use in prior lines of therapy on the ORR and PFS observed with these nal-IRI containing treatment regimens

Вмешательства

• Препарат Liposomal irinotecan
  50mg/m2 IV on days 1 and 15
• Препарат TAS102
  35mg/m2 PO BID on days 1-5 and 15-19
• Препарат Bevacizumab
  5mg/kg IV on days 1 and 15

Первичные конечные точки

• Progression Free Survival (PFS) [Срок оценки: up to 2 years]

Вторичные конечные точки (4)

• Objective Response Rate (ORR) [Срок оценки: up to 2 years]
• Number of Participants Experiencing Grade 3 and 4 Toxicities [Срок оценки: up to 30 days post-treatment (approximately 6 months on study)]
• Summary of Grade 3 and 4 Toxicities by Count of participants [Срок оценки: up to 30 days post-treatment (approximately 6 months on study)]
• Efficacy of irinotecan measured by PFS for patients with and without irinotecan containing regimens [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

• Patients must be ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance must be 0 or 1.
• Patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable.
• The cancer must be mismatch repair proficient.
• Patients must have had prior treatment with 5-fluorouracil, oxaliplatin, irinotecan containing regimens. If RAS wild-type must have received prior anti-EGFR therapy with either cetuximab or panitumumab. If RAS wild-type and HER2 positive then must have had a prior HER2 targeted therapy.

Критерии исключения

• Uncontrolled concurrent medical illness that would not allow for the completion of the planned therapy.
• Patients whose cancers possess BRAF V600 mutations are excluded.
• Patients must stop the use of strong inducers/inhibitors of CYP3A4 at least 2 weeks before initiating therapy.
• Patients must not have mismatch repair deficient or microsatellite instability high cancers.
• Patients must not have received prior TAS102.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Wisconsin Carbone Cancer Center — Madison

Идентификаторы

NCT: NCT05854498 · 2023-0449 · Protocol Version 12/6/2025 · UW23016 · SMPH/MEDICINE/HEM-ONC · NCI-2023-05190

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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