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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-22

Study Completion Date

2022-03-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer Metastatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.

Group Type OTHER

Based on sensitivity analysis

Intervention Type DRUG

* 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No