PROSPECT-C: A Study of Biomarkers of Response or Resistance to Anti-EGFR Therapies in Metastatic Colorectal Cancer

NCT02994888 | Completed

• 1 other identifier: 3770
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

PROSPECT-C is a phase II study investigating the molecular markers of response or resistance to anti-epidermal growth factor receptor (EGFR) antibodies.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Track and validate specific known mechanisms of resistance/response to anti-EGFR therapies through

  digital droplet polymerase chain reaction (ddPCR) and ultra deep next generation sequencing (NGS) analyses of circulating tumour deoxyribonucleic acid (ct-DNA) obtained every 4 weeks during the course of treatment. Mutations found in ctDNA will also be analysed in the archival and fresh tissue specimens, used for diagnostic testing and obtained during the study respectively

  3-4 years

Secondary Outcomes (1)

• Identify novel biomarkers of resistance to anti-EGFR therapies through whole exome sequencing

  3-4 years

Study Arms (1)

all patients

All patients will be treated with cetuximab 500mg/m2 every 2 weeks until the time of progression

Drug: Cetuximab

Interventions

Cetuximab DRUG

All patients will be offered cetuximab 500mg/m2 every 2 weeks, until the time of progression

all patients

Eligibility Criteria

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

Study Population

patients with a histologically confirmed diagnosis of metastatic colorectal adenocarcinoma

You may qualify if:

• patients with a histologically confirmed diagnosis of metastatic colorectal adenocarcinoma
• wild-type RAS tumour status by molecular analysis at the Royal Marsden Hospital
• patients with inoperable metastatic colorectal cancer who are scheduled to be treated with cetuximab (or panitumumab) either as monotherapy or in combination with chemotherapy with palliative intent
• patients who have received prior treatment with oxaliplatin, irinotecan and fluoropyrimidine containing chemotherapy regimens OR intolerance/contraindication to either oxaliplatin or irinotecan based chemotherapy, and planned to receive retreatment with EGFR monoclonal antibody (mAB) monotherapy or with EGFR mAB combined with a chemotherapy (irinotecan or oxaliplatin-based) that a patient has already received for a minimum of 3 months during a previous line of therapy.
• patients who have metastatic disease sites which are amenable to core biopsy (preferably liver, soft tissue or nodal disease, with at least one lesion 3cm or more in diameter. If largest lesion 2-3cm diameter, eligibility to be discussed with radiologist prior to study entry)
• patients aged 18 years or older
• able to provide fully informed consent, to comply with the trial and follow-up procedures
• receiving treatment at the Royal Marsden Hospital

You may not qualify if:

• patients who have previously received treatment with cetuximab or panitumumab
• previous malignancy other than colorectal cancer in the past 5 years, other than pre-invasive malignancy of the cervix or basal cell carcinoma, EXCEPT when the patient has histological confirmation of metastatic colorectal cancer at the site that is planned to be biopsied at baseline and on progression of disease
• patients who are being anti-coagulated with warfarin or heparin
• Patients that are participating in another clinical trial involving an investigational medicinal product, unless it is more than 14 days after they have ceased the investigational medicinal product
• Patients that are participating in another research study involving tumour tissue biopsies planned to take place during the time that the patient is participating in this study

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Surrey, Sutton, SM2 5PT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Both fresh frozen tissue and formalin-fixed paraffin-embedded (FFPE) tissue samples will be obtained. In addition, the following blood samples will also be taken; 1. Baseline: an initial 20mL research blood sample (EDTA or equivalent (CPT) tube) will be collected 2. Every 4 weeks until disease progression or patient death: 1 x 10mL research blood sample (EDTA or equivalent (CPT) tube) will be collected 3. At time of progressive disease: final 10mL research blood sample (EDTA or equivalent (CPT) tube)

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: December 16, 2016
• Study Start: November 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 19, 2016

Record last verified: 2016-12

Locations

GB (1)