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

Vejle Hospital

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer Metastatic

Treatments: Drug: Based on sensitivity analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03251612

Tumorspheres Colrec

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Treatment

Other group

Description:

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

Treatment:

Drug: Based on sensitivity analysis