Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to compare progression free survival rates of metastasized colorectal cancer patients refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)); randomized for treatment with TAS-102 (standard-arm) or High Dose Intermittent Sunitinib (700 mg once every 2 weeks). The investigators hypothesis is that treatment with the experimental arm (sunitinib) will provide an improvement in progression free in this patient group.

Clinical Trial Description

Study design: A prospective, open-label, randomized, mono-center, phase II clinical trial (with registration intent).

Hypothesis: The investigators hypothesize a clinically relevant increase in PFS by 3 months; from 2 months as reported for TAS-102 to 5 months in patients treated with sunitinib. They further hypothesize that this will result in a meaningful improvement in Quality of Life (QoL).

Primary Objective: The primary objective of this study is to improve progression free survival (PFS), of patients with metastatic colorectal carcinoma (mCRC) treated with high-dose sunitinib once every 2 weeks to 5 months, compared to the reported 2 months for TAS-102 monotherapy.

Secondary Objective: Secondary objectives include: overall survival (OS), the safety and efficacy of the treatment, the quality of life in the two study arms, the value of phosphoproteomics as a potential predictive biomarker for response to sunitinib, the potential value of blood markers for molecular diagnostics disease and response monitoring and the sensitivity, specificity.

Study Population: Patients eligible for inclusion are at least 18 years of age, with adequate organ function, who have histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented metastatic disease and have an indication for palliative treatment with TAS102 (refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)). Major exclusion criteria include evidence of significant uncontrolled concomitant disease, previous extensive radiotherapy, recent major surgery or infection, unresolved bowel disorders and poorly controlled hypertension. All patients will provide Informed Consent prior to inclusion in the study and during the course of the trial, all relevant data will be stored in electronic Case Report Forms (eCRF).

Treatment Schedule:

After study inclusion, patients will be randomized (1:1) via a centralized randomization system to receive either oral sunitinib (700 mg once every 2 weeks) or TAS-102 (35 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period). Patients will receive treatment until disease progression or discontinuation due to unacceptable toxic effects, withdrawal of consent, or other reason. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03909724
Study type Interventional
Source VU University Medical Center
Contact Sophie Gerritse, M.D
Phone 0031204441909
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date July 1, 2019
Completion date July 1, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT02963831 - A Phase 1/2 Study to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Enrolling by invitation NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Active, not recruiting NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Completed NCT01266564 - An Observational Study of Avastin (Bevacizumab) in Patients With Colorectal Cancer N/A
Recruiting NCT02857270 - A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer Phase 1
Withdrawn NCT00005030 - SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver Phase 1
Recruiting NCT03530267 - Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With Met. Colorectal Cancer Phase 2
Recruiting NCT03422432 - Prophylactic HIPEC for Colorectal Cancers at High Risk of Developing Peritoneal Metastases N/A
Recruiting NCT03555149 - A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC) Phase 1/Phase 2
Recruiting NCT03214939 - Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Colorectal Cancer Early Phase 1
Active, not recruiting NCT01688232 - The Immunoscore as a Prognostic Marker for Patients With a Colorectal Cancer N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Active, not recruiting NCT00578721 - Trial of Aspirin and Arginine Restriction in Colorectal Cancer Phase 2
Recruiting NCT02386826 - INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme Phase 1
Terminated NCT02277093 - Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer Phase 2
Not yet recruiting NCT03083951 - Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL) Phase 4