Status:
COMPLETED
Capecitabine and 131I-huA33 in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 comb...
Detailed Description
This clinical trial tests the combination of humanised A33 monoclonal antibody tagged with radioactive iodine 131 (131I-huA33) together with capecitabine chemotherapy in patients with advanced colorec...
Eligibility Criteria
Inclusion
- Metastatic colorectal cancer.
- Histologically or cytologically proven colorectal cancer.
- Measurable disease on CT scan with at least one lesion \>/= 2cm diameter (to allow adequate infusion imaging).
- Expected survival of at least 4 months.
- ECOG performance status 0-2.
- Vital laboratory parameters should be within normal range including:
- Neutrophils \>/= 1.5 x 10\^9/L;
- Platelets \>/= 150 x 10\^9/L;
- Serum bilirubin \</= 34 micromol/L;
- Calculated creatinine clearance \> 50 ml/min.
- Age \>/= 18 years.
- Able and willing to give valid written informed consent.
Exclusion
- Previous treatment with capecitabine.
- 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.
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
- Liver involvement with metastatic disease \> 50% liver volume.
- Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
- 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.
- Previous treatment with a monoclonal antibody or antibody fragment AND a positive huA33 human anti-human antibody (HAHA) titre.
- Concomitant treatment with systemic corticosteroids. Topical or inhalational corticosteroids are permitted.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- Lack of availability of the patient for clinical and laboratory follow-up assessment.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Pregnancy or breastfeeding.
- Women of childbearing potential: Refusal or inability to use effective means of contraception.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00291486
Start Date
October 1 2003
End Date
August 29 2012
Last Update
October 10 2022
Active Locations (1)
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1
Ludwig Institute Oncology Unit and Tumor Targeting Program, Austin Health
Heidelberg, Victoria, Australia, 3084