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

Colorectal Cancer Clinical Trial

— ABX067  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625573
• Other study ID #: COL-01
• Status: Completed
• Phase: Phase 2
• First received: February 19, 2008
• Last updated: September 17, 2009
• Start date: September 2007
• Est. completion date: March 2009

Study information

• Verified date: September 2009
• Source: Mt. Sinai Medical Center, Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	Miami Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mt. Sinai Medical Center, Miami	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate overall survival, time to progression, response duration, time to response and safety of this combination		One Year