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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

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Abraxane Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
Study Start Date : September 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Abraxane
    100mg/m2 every week X's 3


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate overall survival, time to progression, response duration, time to response and safety of this combination [ Time Frame: One Year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625573


Locations
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United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
Celgene Corporation
Investigators
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Principal Investigator: Joseph Pizzolato, MD Mt. Sinai Medical Center Miami Beach Florida

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Responsible Party: Joseph Pizzolato, M.D., Mt. Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00625573     History of Changes
Other Study ID Numbers: COL-01
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Mt. Sinai Medical Center, Miami:
Colon Cancer
Abraxis Oncology
Abraxane
Phase II
Colorectal
Mt. Sinai Medical Center
CCOP

Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Albumin-Bound Paclitaxel
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators