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

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier:
NCT00625573
First received: February 19, 2008
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: Abraxane
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)

Resource links provided by NLM:


Further study details as provided by Mt. Sinai Medical Center, Miami:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate overall survival, time to progression, response duration, time to response and safety of this combination [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 29
Study Start Date: September 2007
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Abraxane
    100mg/m2 every week X's 3
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
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625573

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

No publications provided

Responsible Party: Joseph Pizzolato, M.D., Mt. Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00625573     History of Changes
Other Study ID Numbers: COL-01
Study First Received: February 19, 2008
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 18, 2014