Trials / Completed
CompletedNCT04109924
TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study
A Phase II Study of TAS-102, Irinotecan and Bevacizumab in Pre-Treated Metastatic Colorectal Cancer (TABAsCO)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well TAS-102, irinotecan, and bevacizumab work in treating patients with pre-treated colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving TAS-102, irinotecan, and bevacizumab may work better in treating patients with colorectal cancer compared to traditional chemotherapy and bevacizumab.
Detailed description
PRIMARY OBJECTIVE: I. Determine the median progression free survival (PFS) benefit of leucovorin calcium, 5-fluorouracil, and irinotecan (FOLFIRI) naive patients treated with trifluridine and tipiracil hydrochloride (TAS-102) + irinotecan + bevacizumab as compared to historic control groups treated with FOLFIRI + bevacizumab. SECONDARY OBJECTIVE: I. Estimate the objective response rate (ORR), median overall survival (OS), and adverse event (AE) profile. OUTLINE: Patients receive irinotecan intravenously (IV) over 90 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also receive trifluridine and tipiracil hydrochloride orally (PO) twice daily (BID) on days 2-6 and 16-20. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 months for up to 2 years.
Conditions
- Advanced Colorectal Carcinoma
- Metastatic Colon Adenocarcinoma
- Metastatic Rectal Adenocarcinoma
- Recurrent Colon Adenocarcinoma
- Recurrent Colorectal Adenocarcinoma
- Recurrent Rectal Adenocarcinoma
- Stage III Colon Cancer AJCC v8
- Stage III Colorectal Cancer AJCC v8
- Stage III Rectal Cancer AJCC v8
- Stage IIIA Colon Cancer AJCC v8
- Stage IIIA Colorectal Cancer AJCC v8
- Stage IIIB Colorectal Cancer AJCC v8
- Stage IIIB Rectal Cancer AJCC v8
- Stage IIIC Colon Cancer AJCC v8
- Stage IIIC Colorectal Cancer AJCC v8
- Stage IV Colon Cancer AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVA Rectal Cancer AJCC v8
- Stage IVB Colon Cancer AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage IVB Rectal Cancer AJCC v8
- Stage IVC Colon Cancer AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
- Stage IVC Rectal Cancer AJCC v8
- Unresectable Colon Adenocarcinoma
- Unresectable Colorectal Carcinoma
- Unresectable Rectal Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Irinotecan | Given IV |
| BIOLOGICAL | Bevacizumab | Given IV |
| DRUG | Trifluridine and Tipiracil Hydrochloride | Given PO |
Timeline
- Start date
- 2019-12-27
- Primary completion
- 2024-09-05
- Completion
- 2024-09-05
- First posted
- 2019-10-01
- Last updated
- 2026-02-10
- Results posted
- 2026-02-10
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04109924. Inclusion in this directory is not an endorsement.