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

NCT00625573 | Completed Phase 2 DMC

• 1 other identifier: COL-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Keywords

Colon Cancer; Abraxis Oncology; Abraxane; Phase II; Colorectal; Mt. Sinai Medical Center; CCOP

Outcome Measures

Primary Outcomes (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

  One year

Secondary Outcomes (1)

• To evaluate overall survival, time to progression, response duration, time to response and safety of this combination

  One Year

Interventions

Abraxane DRUG

100mg/m2 every week X's 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mt. Sinai Medical Center, Miami: lead
• Celgene Corporation: collaborator

Study Sites (1)

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Joseph Pizzolato, MD

  Mt. Sinai Medical Center Miami Beach Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: September 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

US (1)