Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
- Signed written informed consent
- Patients with histologically or cytologically confirmed stage IV colorectal cancer who
have failed either irinotecan-based, oxaliplatin-based or both. ECOG performance status
- Presence of measurable disease by radiographic study (including CT or MRI scan, or
chest x-ray) or physical examination
- At least 3 weeks since last major surgery.
- At least 6 weeks since prior radiotherapy providing that the extent and site of
radiotherapy fields are such that marked bone marrow suppression is NOT expected.
Patients who have received palliative radiotherapy must have recovered from any
reversible toxic effects e.g. nausea and vomiting caused by radiation of fields.
- At least 4 weeks since prior chemotherapy.
- Pt with reproductive potential must use effective BC
Required Screening Laboratory Criteria:
- Hemoglobin 9.0g/dL
- WBC 3,500/mm3 [ 3.5 x 109/L]
- Neutrophils 1,500/mm3 [1.5 x 109/L]
- Platelets 100,000/mm3 [ 100.0 x 109/L]
- Creatinine 1.5 mg/dL (133 micromol/L) AND creatinine clearance 60 mL/min • A probable
life expectancy of at least 6 months.
- No brain metastases.
- If female of childbearing potential, pregnancy test is negative.
- Concomitant malignancies or previous malignancies other than colorectal cancer within
the last five years, with the exception of adequately treated basal or squamous cell
carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer.
- Active infection.
- Concurrent severe medical problems unrelated to the malignancy, which would
significantly limit full compliance with the study or expose the patient to extreme
- Sexually active patients refusing to practice adequate contraception. (condom plus
spermicide, or other form of birth control)
- Patients with conditions which might affect absorption of an oral drug (for example
intermittent obstruction) should be excluded unless discussed and agreed with the
- History of grade 3 or 4 toxicity to fluoropyrimidines.
- Pre-existing neuropathy ≥ NCI CTC grade 2
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy by means of response rate of Abraxane and capecitabine in combination, in the treatment of patients with colorectal cancer in the 2nd or 3rd line metastatic setting following failure of irinotecan or oxaliplatin based therapy
Joseph Pizzolato, MD
Mt. Sinai Medical Center Miami Beach Florida
United States: Institutional Review Board
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