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

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vejle Hospital

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