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Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)


Phase 2
18 Years
90 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

One year

Safety Issue:

Yes

Principal Investigator

Joseph Pizzolato, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mt. Sinai Medical Center Miami Beach Florida

Authority:

United States: Institutional Review Board

Study ID:

COL-01

NCT ID:

NCT00625573

Start Date:

September 2007

Completion Date:

March 2009

Related Keywords:

  • Colorectal Cancer
  • Colon Cancer
  • Abraxis Oncology
  • Abraxane
  • Phase II
  • Colorectal
  • Mt. Sinai Medical Center
  • CCOP
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

Mount Sinai Medical CenterMiami Beach, Florida  33140