Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer Metastatic
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Based on sensitivity analysis
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer Metastatic
Eligibility Criteria
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
Sites / Locations
- Department of Oncology, Aalborg University Hospital
- Department of Oncology, Rigshospitalet
- Departmen of Oncology, Vejle Hospital
- Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment
Arm Description
1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.
Outcomes
Primary Outcome Measures
Progression free survival 8 weeks after start of treatment
Secondary Outcome Measures
Progression free survival
Overall survival
Response rate
Quality of life as measured by questionnaire EQ-5D-5L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03251612
Brief Title
Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
Official Title
Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
August 23, 2021 (Actual)
Study Completion Date
March 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Arm Description
1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.
Intervention Type
Drug
Intervention Name(s)
Based on sensitivity analysis
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression free survival 8 weeks after start of treatment
Time Frame
42-63 days after start of treatment
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
Every 8 weeks until progression or death up to 2.5 years
Title
Overall survival
Time Frame
Every 3 months up to 2.5 years
Title
Response rate
Time Frame
Every 8 weeks until progression up to 2.5 years
Title
Quality of life as measured by questionnaire EQ-5D-5L
Time Frame
Every 8 weeks up to 2.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars H Jensen, MD
Organizational Affiliation
Vejle Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Oncology, Aalborg University Hospital
City
Aalborg
Country
Denmark
Facility Name
Department of Oncology, Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Departmen of Oncology, Vejle Hospital
City
Vejle
Country
Denmark
Facility Name
Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH)
City
Hamburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
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