Capecitabine and 131I-huA33 in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 combination with chemotherapy (capecitabine).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig Institute for Cancer Research
• Treatments: Antibodies; Antibodies, Monoclonal; Capecitabine

Criteria

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.