Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      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
    

Detailed description: 
      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
    

Intervention name(s): Abraxane
Intervention type(s): Drug
Intervention description(s): 100mg/m2 every week X's 3
Intervention MeSH terms: Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colon Cancer; Abraxis Oncology; Abraxane; Phase II; Colorectal; Mt. Sinai Medical Center; CCOP