MicroOrganoSphere Drug Screen Pilot Trial in Colorectal Cancer (CRC)

Overview

About this study

The primary objective of this study is to determine the feasibility of generating sufficient MicroOrganpSphere (MOS) from a biopsy of a patient's colorectal cancer liver metastasis to determine sensitivity to standard of care drug used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/Xeloda, Bevacizumab, Panitumumab or Cetuximab, Lonsurf, Regorafenib and Pembrolizumab or Nivolumab) in < 14 days.

The secondary objective of this study is to assess the association between standard of care drug sensitivity in MOS to clinical outcome of patient treated with standard of care therapy from which the MOS was derived.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Subjects may participate in this study if all of the following criteria apply:

  • Provide written informed consent.
  • Male or female ages 18 or older.
  • Evidence of cancer of the colon or rectum that is metastatic to the liver.
    • NOTE:  patients may enroll prior to receiving clinical biopsy results. If they are not confirmed to have adenocarcinoma of the colon or rectum that is metastatic to the liver, they will not be evaluable.
  • Treating physician planning to treat CRC liver metastasis with a standard of care therapy.
  • Previous adjuvant or neoadjuvant therapies allowed.
  • Biopsy may be obtained prior to starting the 2nd cycle of a new standard of care therapy.
  • Measurable disease as measured by RECIST 1.1 criteria.
  • Life expectancy of ≥ 12 weeks.
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2. 
  • Adequate coagulation function as evidenced by:
    • Absolute neutrophil count ≥ 1.0 x 10^9/L;
    • Platelets ≥ 50 x 10^9/L;
    • Hemoglobin ≥ 8 g/dL (transfusions are permitted to achieve baseline hemoglobin level);
  • ALT/AST (alanine aminotransferase (ALT) / aspartate aminotransferase (AST)) < 2.5 x upper limit of normal (ULN); or
  • < 5 x ULN in the presence of liver metastases;
  • Total bilirubin < 1.5 x ULN (if total bilirubin ≥ 1.5 x ULN then the subject may participate if the direct bilirubin is ≤ 1.5 x ULN);
  • Creatinine clearance > 30 mL/min measured or calculated by Cockcroft-Gault equation or the estimated glomerular filtration rate (GFR) > 30 mL/min/1.73 m^2 using the MDRD;
  • INR < 1.5.

Exclusion Criteria:

Subjects may not participate if any of the following criteria apply:

  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
  • Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from day 1 of start of therapy, New York Heart Association Class II, III or IV congestive heart failure, and arrhythmia requiring therapy.
  • Presence of significant concurrent, uncontrolled medical condition including but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, active infection, non-healing wound, or psychiatric disease that excludes them from receiving chemotherapy.
  • Pregnant or actively breastfeeding women (Pregnant or breastfeeding women are not candidates for chemotherapy).

Eligibility last updated 7/20/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hao Xie, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Jeremy Jones, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Christina Wu, M.B., B.Ch., M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions