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

NCT ID: NCT00625573

Last Updated: 2009-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-03-31

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

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Abraxane

100mg/m2 every week X's 3

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Mt. Sinai Medical Center, Miami

OTHER

Sponsor Role: lead

Responsible Party

Mt. Sinai Medical Center

Principal Investigators

Joseph Pizzolato, MD

Role: PRINCIPAL_INVESTIGATOR

Mt. Sinai Medical Center Miami Beach Florida

Locations

Mount Sinai Medical Center

Miami Beach, Florida, United States

Countries

United States

Other Identifiers

COL-01

Identifier Type: -

Identifier Source: org_study_id