Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
Overview[ - collapse ][ - ]
| 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 |
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| Condition | Colorectal Cancer |
| Intervention | Drug: Abraxane |
| Phase | Phase 2 |
| Sponsor | Mt. Sinai Medical Center, Miami |
| Responsible Party | Mt. Sinai Medical Center, Miami |
| ClinicalTrials.gov Identifier | NCT00625573 |
| First Received | February 19, 2008 |
| Last Updated | September 17, 2009 |
| Last verified | September 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 19, 2008 |
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| Last Updated Date | September 17, 2009 |
| Start Date | September 2007 |
| Estimated Primary Completion Date | March 2009 |
| Current 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] |
| Current 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] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01) |
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| Official Title | Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01) |
| 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 |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Colorectal Cancer |
| Intervention | Drug: Abraxane 100mg/m2 every week X's 3 |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
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| Estimated Enrollment | 29 |
| Estimated Completion Date | March 2009 |
| Estimated Primary Completion Date | February 2009 |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00625573 |
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| Other Study ID Numbers | COL-01 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Mt. Sinai Medical Center, Miami |
| Study Sponsor | Mt. Sinai Medical Center, Miami |
| Collaborators | Celgene Corporation |
| Investigators | Principal Investigator: Joseph Pizzolato, MD Mt. Sinai Medical Center Miami Beach Florida |
| Verification Date | September 2009 |
Locations[ + expand ][ + ]
| Mount Sinai Medical Center | Miami Beach, Florida, United States, 33140 |
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