Colorectal CancerPhase 2ABX067NCT00625573
Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
A Phase 2 study testing Abraxane in people with Colorectal Cancer, run by Mt. Sinai Medical Center, Miami at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Abraxane
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
Miami Beach, Florida, 33140
About this study
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
Read the 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
- Being tested
- Abraxane
- Keywords
- Colon Cancer, Abraxis Oncology, Abraxane, Phase II, Colorectal, Mt. Sinai Medical Center, CCOP
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
100mg/m2 every week X's 3
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Secondary outcomes (1)
To evaluate overall survival, time to progression, response duration, time to response and safety of this combination
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mt. Sinai Medical Center, Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Investigators
- Joseph Pizzolato, MD, Principal investigator, Mt. Sinai Medical Center Miami Beach Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625573
- Sponsor's protocol ID
- COL-01
- Acronym
- ABX067
- Status last verified
- Sep 2009
- First submitted
- 19 Feb 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
- ClinicalTrials.gov ID
- NCT00625573
- Acronym / sponsor ID
- ABX067 / COL-01
- Conditions
- Colorectal Cancer
- Keywords
- Colon Cancer, Abraxis Oncology, Abraxane, Phase II, Colorectal, Mt. Sinai Medical Center, CCOP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Mt. Sinai Medical Center, MiamiUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Sep 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abraxane100mg/m2 every week X's 3 | Drug | – |
Primary outcome
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
1 secondary outcome
To evaluate overall survival, time to progression, response duration, time to response and safety of this combination
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Pizzolato, MD principal investigator
Mt. Sinai Medical Center Miami Beach Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abraxane in people with Colorectal Cancer, run by Mt. Sinai Medical Center, Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2009.