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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer Metastatic
• Intervention / Treatment: Drug: Based on sensitivity analysis

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment; 1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival 8 weeks after start of treatment	42-63 days after start of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	Every 8 weeks until progression or death up to 2.5 years
Overall survival	Every 3 months up to 2.5 years
Response rate	Every 8 weeks until progression up to 2.5 years
Quality of life as measured by questionnaire EQ-5D-5L	Every 8 weeks up to 2.5 years

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Study Chair: Lars H Jensen, MD, Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): August 23, 2021
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Tumorspheres Colrec

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No