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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00291486 |
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Date of registration:
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10/02/2006 |
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Primary sponsor: |
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Public title:
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Capecitabine and 131I-huA33 in Patients With Metastatic Colorectal Cancer
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Scientific title:
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Phase I Trial of Oral Capecitabine Combined With 131I-huA33 in Patients With Metastatic Colorectal Cancer |
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Date of first enrolment:
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October 2003 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00291486 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Contacts
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Name:
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Prof. Andrew M Scott, MBBS, DDU MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ludwig Institute for Cancer Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Metastatic colorectal cancer
- Histologically or cytologically proven colorectal cancer
- Measurable disease on CT scan with at least one lesion >/= 2cm diameter (to allow
adequate scout infusion imaging)
- Expected survival of at least 4 months.
- ECOG performance status 0-2.
- Vital laboratory parameters should be within normal range including:
1. Neutrophils >/= 1.5 x 10^9/L;
2. Platelets >/= 150 x 10^9/L;
3. Serum bilirubin
4. calculated creatinine clearance > 50 ml/min
- Age >/= 18 years
- Able and willing to give valid written informed consent
Exclusion Criteria:
- 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 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Neoplasms
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Intervention(s)
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Drug: 131I-huA33 (131-Iodine on humanised monoclonal antibody A33)
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Drug: Capecitabine
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Primary Outcome(s)
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- Safety and tolerability of 131I-huA33 combined with capecitabine (NCI-CTCAE)
[Time Frame: 13 weeks]
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Secondary Outcome(s)
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Biodistribution of 131I-huA33 when combined with capecitabine measured by gamma camera planar and SPECT image analysis;
[Time Frame: 6 weeks]
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Immune response (HAHA) to 131I-huA33 when combined with capecitabine, measured by blood sample analysis.
[Time Frame: 13 weeks]
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Pharmacokinetics of 131I-huA33 when combined with capecitabine, measured by blood sample analysis (gamma scintillation);
[Time Frame: 6 weeks]
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Tumour response (RECIST) to 131I-huA33 when combined with capecitabine, measured with radiological imaging (scans)
[Time Frame: 13 weeks]
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Secondary ID(s)
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LUD2002-017
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NIH grant R21-CA108145-01A1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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