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Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01) (ABX067)

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ClinicalTrials.gov Identifier: NCT00625573
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : September 18, 2009
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Mt. Sinai Medical Center, Miami

Tracking Information
First Submitted Date  ICMJE February 19, 2008
First Posted Date  ICMJE February 28, 2008
Last Update Posted Date September 18, 2009
Study Start Date  ICMJE September 2007
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
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 [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00625573 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
To evaluate overall survival, time to progression, response duration, time to response and safety of this combination [ Time Frame: One Year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
Official Title  ICMJE Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
Brief 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: Abraxane
100mg/m2 every week X's 3
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 27, 2008)
29
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625573
Other Study ID Numbers  ICMJE COL-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Pizzolato, M.D., Mt. Sinai Medical Center
Study Sponsor  ICMJE Mt. Sinai Medical Center, Miami
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Joseph Pizzolato, MD Mt. Sinai Medical Center Miami Beach Florida
PRS Account Mt. Sinai Medical Center, Miami
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP