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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Abraxane

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: Interventional
• Enrollment (Anticipated): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate overall survival, time to progression, response duration, time to response and safety of this combination	One Year

Collaborators and Investigators

• Sponsor: Mt. Sinai Medical Center, Miami
• Collaborators: Celgene Corporation
• Investigators: Principal Investigator: Joseph Pizzolato, MD, Mt. Sinai Medical Center Miami Beach Florida

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 19, 2008
• First Submitted That Met QC Criteria: February 27, 2008
• First Posted (Estimate): February 28, 2008

Study Record Updates

• Last Update Posted (Estimate): September 18, 2009
• Last Update Submitted That Met QC Criteria: September 17, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Phase II; Abraxane; Colon Cancer; Colorectal; Abraxis Oncology; Mt. Sinai Medical Center; CCOP
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Antineoplastic Agents; Albumin-Bound Paclitaxel
• Other Study ID Numbers: COL-01