Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
This is an open-label, phase II study to evaluate the efficacy and safety of Abraxane in
 combination with Capecitabine in patients with metastatic colorectal cancer in the second or
 third line
Inclusion Criteria

 -  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
 of 0-2

 -  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.

 Exclusion Criteria

 -  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
 risk.

 -  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
 principal investigator

 -  History of grade 3 or 4 toxicity to fluoropyrimidines.

 -  Pre-existing neuropathy ≥ NCI CTC grade 2
Inclusion Criteria:

 -  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 of 0-2

 -  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

 Exclusion Criteria:

 -  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
 risk.

 -  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
 principal investigator

 -  History of grade 3 or 4 toxicity to fluoropyrimidines.

 -  Pre-existing neuropathy ≥ NCI CTC grade 2.