Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Advanced Colorectal Carcinoma
  • Carcinoma
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Metastatic Colon Adenocarcinoma
  • Metastatic Rectal Adenocarcinoma
  • Rectal Neoplasms
  • Recurrence
  • 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

NCT number NCT04109924
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 27, 2019
Completion date July 17, 2024

See also
  Status Clinical Trial Phase
Terminated NCT04832763 - Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer N/A
Active, not recruiting NCT04164069 - Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab Phase 1
Active, not recruiting NCT03981614 - Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer Phase 2
Completed NCT04597151 - Diet Education Program for Stage I-IV Colorectal Cancer Survivors N/A
Recruiting NCT04739072 - Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
Suspended NCT04111172 - A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma Phase 2
Active, not recruiting NCT04362839 - Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer Phase 1
Active, not recruiting NCT04117945 - Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer Phase 2
Active, not recruiting NCT02983578 - Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer Phase 2
Recruiting NCT04693377 - Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial N/A
Completed NCT00862680 - 4D PET/CT in Diagnosing Participants With Lung and Colorectal Cancer With Liver and Lung Metastasis
Recruiting NCT04511039 - Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer Phase 1
Completed NCT04067960 - Pharmacogenomics Testing in Directing the Optimal Use of Supportive Care Medications in Patients With Stage III-IV Cancer Early Phase 1
Recruiting NCT04017650 - Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT03844750 - Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hepatic Metastases Phase 2
Active, not recruiting NCT03599752 - Chemotherapy and/or Metastasectomy in Treating Patients With Metastatic Colorectal Adenocarcinoma With Lung Metastases Phase 2
Active, not recruiting NCT03993327 - An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer Phase 1
Withdrawn NCT03576963 - Guadecitabine and Nivolumab in Treating Refractory Metastatic Colorectal Cancer Phase 1/Phase 2
Active, not recruiting NCT03844620 - Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer Phase 2
Recruiting NCT04771520 - Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors Phase 2