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Clinical Trial · NCT00291486
Capecitabine and 131I-huA33 in Patients With Metastatic Colorectal Cancer
Overview
The purpose of this clinical trial is to determine whether it is safe to treat patients with advanced colorectal cancer, with humanised A33 antibody tagged with radioactive iodine (131I-huA33) in combination with chemotherapy (capecitabine).
Sponsor
Olivia Newton-John Cancer Research Institute
Phase
Phase 1
Contacts
Prof. Andrew M Scott, MBBS, DDU MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT00291486Drug / Compound
huA33
Isotope(s):
IODINE-131
Radioisotope: I-131
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 8 Days
Decay Mode: BETA, GAMMA
Energy: βeta max 0.6 MeV Gamma 364 keV
Range: In Tissue: 0.8 -2.1 mm
Decay Daughters: Xe131
Status: FDA Approval: 1951-First FDA Approved Radiopharmaceutical), AZEDRA® (2018)
Target(s):
- GPA33
Ligand Class: Antibodies
Eligibility
Inclusion
- Calculated creatinine clearance \> 50 ml/min.
- Histologically or cytologically proven colorectal cancer.
Exclusion
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
- Previous external beam irradiation except if: (i) it was for standard adjuvant pelvic radiation for rectal cancer; (ii) it was for localised irradiation for skin cancer; or (iii) the sum total of all previous external beam irradiation port areas is not greater than 25% of the total red marrow.
- Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
- Liver involvement with metastatic disease \> 50% liver volume.
- Untreated active metastatic disease to the central nervous system (new or enlarging lesions on CT or MRI), or within 3 months of treatment (ie surgery or radiotherapy) for brain metastases.
- Concomitant treatment with systemic corticosteroids. Topical or inhalational corticosteroids are permitted.
- Previous treatment with a monoclonal antibody or antibody fragment AND a positive huA33 human anti-human antibody (HAHA) titre.
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