Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer

Colorectal Cancer Metastatic Clinical Trial

Official title:

Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251612
• Other study ID #: Tumorspheres Colrec
• Status: Completed
• Phase: Phase 2
• Start date: September 22, 2017
• Est. completion date: March 21, 2022

Study information

• Verified date: January 2023
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study is to investigate the benefit of anti-cancer therapy administered on the basis of drug sensitivity testing. This concerns colorectal cancer patients who have previously received standard treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 21, 2022
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Metastatic colorectal cancer
• Biopsy proven adenocarcinoma compatible with colorectal origin (primary tumor or metastasis)
• If only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the colon or rectum (scanning or endoscopy)
• Non-resectable metastatic spread
• Previously exposed to or intolerance or contraindications to standard systemic therapy, defined as
• oxaliplatin
• irinotecan
• 5-fluorouracil (or similar such as capecitabine, S1)
• VEGF inhibitor bevacizumab
• EGFR inhibitor panitumumab or cetuximab (if RAS/RAF wt)
• Progressive disease defined as progression according to RECIST 1.1
• ECOG performance status 0-2
• Age at least 18 years
• Adequate bone marrow, liver and renal function allowing systemic chemotherapy
• Absolute neutrophil count =1.5x10^9/l and thrombocytes = 100x10^9/l.
• Bilirubin = 1.5 x upper normal value and alanine aminotransferase = 3 x upper normal value
• Calculated or measured renal glomerular filtration rate at least 30 mL/min
• Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
• Written and orally informed consent

Exclusion Criteria:

• Incapacity, frailty, disability, or comorbidity to a degree that according to the investigator is not compatible with participation in the protocol
• Other active malignant disease requiring therapy
• Other systemic anti-cancer therapy (palliative radiotherapy is allowed).
• Pregnant (positive pregnancy test) or breast feeding women

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• Based on sensitivity analysis
5FU, infusional Capecitabine Oxaliplatin (FOLFOX) Irinotecan (FOLFIRI) FOLFOXIRI (triplet) Bevacizumab Panitumumab Cetuximab Regorafenib Tas-102 Ramucirumab Aflibercept Pembrolizumab Nivolumab Vinorelbine and capecitabine Sorafenib Gemcitabine and capecitabine Olaparib Epirubicin

Locations

Country	Name	City	State
Denmark	Department of Oncology, Aalborg University Hospital	Aalborg
Denmark	Department of Oncology, Rigshospitalet	Copenhagen
Denmark	Departmen of Oncology, Vejle Hospital	Vejle
Germany	Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH)	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Countries where clinical trial is conducted

Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival 8 weeks after start of treatment		42-63 days after start of treatment
Secondary	Progression free survival		Every 8 weeks until progression or death up to 2.5 years
Secondary	Overall survival		Every 3 months up to 2.5 years
Secondary	Response rate		Every 8 weeks until progression up to 2.5 years
Secondary	Quality of life as measured by questionnaire EQ-5D-5L		Every 8 weeks up to 2.5 years