lead-in FOLICOLOR Trial: Following Therapy Response Through Liquid Biopsy in Metastatic Colorectal Cancer Patients

NCT04735900 | Unknown

• 1 other identifier: 20/17/224
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief Summary

Detection of progressive disease by neuropeptide Y (NPY) methylation in liquid biopsies in patients with RAS and BRAF wild-type, unresectable, metastatic colorectal cancer receiving first-line treatment FOLFOX/FOLFIRI and panitumumab.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Optimize cutoff value

  Optimization of the cutoff value for NPY methylation in liquid biopsies (ctDNA) in metastatic colorectal cancer patients receiving first-line FOLFOX/FOLFIRI and panitumumab to discriminate between progressive and non-progressive disease as determined by CT scans based on RECIST criteria 1.1. To this end, a Receiver Operating Characteristic (ROC) curve will be developed with data of this study.

  Start cycle 1 of first-line FOLFOX/FOLFIRI and panitumumab therapy until the day on which the first CT scan is performed following the liquid biopsies taken 9 months after the start of first-line therapy, or when 11 months of follow-up is reached.

Secondary Outcomes (1)

• Determine progression free and 9-month survival

  Start cycle 1 of first-line FOLFOX/FOLFIRI and panitumumab therapy until the day on which the first CT scan is performed following the liquid biopsies taken 9 months after the start of first-line therapy, or when 11 months of follow-up is reached.

Other Outcomes (3)

• Exploratory objective 1

  Start cycle 1 of first-line FOLFOX/FOLFIRI and panitumumab therapy until the day on which the first CT scan is performed following the liquid biopsies taken 9 months after the start of first-line therapy, or when 11 months of follow-up is reached.

• Exploratory objective 2

  Start cycle 1 of first-line FOLFOX/FOLFIRI and panitumumab therapy until the day on which the first CT scan is performed following the liquid biopsies taken 9 months after the start of first-line therapy, or when 11 months of follow-up is reached.

• Exploratory objective 3

  Start cycle 1 of first-line FOLFOX/FOLFIRI and panitumumab therapy until the day on which the first CT scan is performed following the liquid biopsies taken 9 months after the start of first-line therapy, or when 11 months of follow-up is reached.

Study Arms (1)

First-line FOLFOX/FOLFIRI and panitumumab.

EXPERIMENTAL

Chemotherapeutic agents will be given as an intravenous infusion at a dose and interval consistent with standard institutional practice.

Procedure: Liquid biopsy sampling

Interventions

Liquid biopsy sampling PROCEDURE

Biweekly liquid biopsy sampling to measure circulating tumor DNA (ctDNA) level up to and including 9 months after start first-line therapy.

First-line FOLFOX/FOLFIRI and panitumumab.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman ≥ 18 years of age at the time the informed consent is obtained
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1
• Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease
• Wild-type RAS tumor status (of tumor tissue)
• Wild-type BRAF tumor status (of tumor tissue)
• Adequate hematologic, renal, hepatic and coagulation function
• Starting a first-line treatment with a combination of FOLFOX/FOLFIRI and panitumumab

You may not qualify if:

• History of prior or concurrent central nervous system metastases
• History of other malignancy, except:
• Malignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to start therapy and felt to be at low risk for recurrence by the treating physician
• Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
• Adequately treated cervical carcinoma in situ without evidence of disease
• Prostatic intraepithelial neoplasia without evidence of prostate cancer
• Prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic colorectal carcinoma including but not limited to bevacizumab and anti-Epidermal Growth Factor Receptor (EGFR) therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)
• Prior adjuvant chemotherapy (including oxaliplatin therapy) or other adjuvant systemic anticancer therapy including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) for the treatment of colorectal cancer ≤ 6 months prior to start therapy with the following exceptions:
• Subjects may have received prior fluoropyrimidine therapy if administered solely for the purpose of radiosensitization for the adjuvant or neoadjuvant treatment of rectal cancer
• Radiotherapy ≤ 14 days prior to start therapy. Subjects must have recovered from all radiotherapy-related toxicities.
• Significant cardiovascular risk
• History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on diagnostic CT scan
• Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as ≥ Common Terminology Criteria (CTC) grade 2, \[Common Terminology Criteria for Adverse Events (CTCAE) version 5.0\])
• Peripheral sensory neuropathy (≥ CTC grade 2 \[CTCAE version 5.0\])

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Amgen: collaborator

Study Sites (6)

AZ Klina

Brasschaat, 2930, Belgium

RECRUITING

Antwerp University Hospital (UZA)

Edegem, 2650, Belgium

RECRUITING

AZ Maria Middelares

Ghent, 9000, Belgium

RECRUITING

AZ Groeninge

Kortrijk, 8500, Belgium

RECRUITING

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

RECRUITING

GZA

Wilrijk, 2610, Belgium

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Marc Peeters, MD, PhD

  Antwerp University Hospital (UZA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silke Raats

CONTACT

+32 3 821 42 15; folicolor@uza.be

Katleen Janssens, MD

CONTACT

+32 3 275 97 80; katleen.janssens@student.uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: February 3, 2021
• Study Start: September 14, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 3, 2021

Record last verified: 2021-01

Locations

BE (6)