Colorectal CancerPhase 2NCT01730586
Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas
A Phase 2 study testing Abraxane in people with Colorectal Cancer and Cancer of Gastrointestinal Tract, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if abraxane can help to control colorectal and/or small bowel cancer. The safety of this drug will also be studied. Abraxane is designed to block cancer cells from dividing, which may cause them to die. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Cancer of Gastrointestinal Tract
- What is being tested?
- Abraxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Aug 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have histologically or cytologically confirmed colorectal adenocarcinoma or small bowel adenocarcinoma
- Metastatic disease documented on diagnostic imaging studies with measurable disease per RECIST version 1.1.
- Refractory disease defined as: a) prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and anti-epidermal growth factor receptor (EGFR) therapy if Kirsten rat sarcoma (KRAS) wildtype for colorectal adenocarcinoma and; b) prior treatment with fluoropyrimidine and oxaliplatin for small bowel adenocarcinoma.
- Colorectal adenocarcinoma patients must be known to have CpG island methylator phenotype. CIMP-high phenotype will be defined as hypermethylation at 2 or more of the 6 methylation-specific PCR markers (hMLH1, P16, P14, MINT1, MINT2, and MINT31).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Adequate organ function including: a) Absolute neutrophil count (ANC) =/>1,500cells/mm^3; b) Platelets =/>100,000/ul; c) Hemoglobin >9.0 g/dL; d) Total bilirubin =/<1.5mg/dL In patients with known Gilbert's syndrome, direct bilirubin =/<1.5 x upper limit of normal (ULN) will be used as organ function criteria, instead of total bilirubin; e) AST and ALT < 2.5 x ULN; f) Alkaline phosphatase <2.5x ULN; g) Creatinine <1.5 gm/dL.
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- Negative serum or urine pregnancy test in women with childbearing potential (WOCBP) defined as not post-menopausal for 12 months or no previous surgical sterilization, within one week prior to initiation of treatment. WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy.
- A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy. If the partner is pregnant or breastfeeding, the subject must use a condom.
- Patients must sign an Informed Consent and Authorization indicating that they are aware of the investigational nature of this study and the known risks involved.
- Patient is =/>18 years of age on the day of consenting to the study.
Who cannot join
- Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)".
- Prior treatment with taxane therapy for either colorectal cancer or small bowel adenocarcinoma.
- Chemotherapy or any other investigational agents within 14 days of first receipt of study treatment, or major surgery within 28 days of first receipt of study treatment, or palliative radiation within 7 days of first receipt of study treatment.
- Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection.
- Pregnancy (positive pregnancy test) or lactation.
- Patients with carcinomatous meningitis.
- Known central nervous system (CNS) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Study of Abraxane in CIMP-High Colorectal Adenocarcinomas and Small Bowel Adenocarcinomas
The goal of this clinical research study is to learn if abraxane can help to control colorectal and/or small bowel cancer. The safety of this drug will also be studied.
Abraxane is designed to block cancer cells from dividing, which may cause them to die.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive the study drug in 21-day study cycles.
You will receive abraxane by vein over about 30 minutes on Day 1 of each cycle.
Study Visits:
On Day 1 of all cycles, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and blood pressure.
- You will be asked about any drugs you may be taking and about any symptoms or side effects you may be having.
- Your performance status will be recorded.
- Blood (about 2 tablespoons) will be drawn for routine tests.
At the end of every 3rd cycle (Cycles 3, 6, 9) and so on:
°You will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease. If at any point the scans show the disease appearing to get better, you will have another scan 2 cycles later.
Length of Treatment:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if you have intolerable side effects, if the study is stopped, or if you are unable to follow study instructions.
Your participation on the study will be over after the follow-up period.
End-of-Treatment Visit:
Within 10 days after you stop taking the study drug, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and blood pressure.
- You will be asked about any drugs you may be taking and about any symptoms or side effects you may be having.
- Your performance status will be recorded.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If one has not been performed in the previous 4 weeks, you will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease.
Follow-Up:
The study staff will ask about any symptoms or side effects you may be having during the 30 days after your last dose of the study drugs. The study staff may ask you by phone or at the time of a routine clinic visit. If the study staff contacts you by phone, the phone call should last about 15-30 minutes.
If you leave the study for any reason other than the disease getting worse, you will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease every 12 weeks unless you start receiving other treatment.
The study staff will also review your medical records and/or contact you to check the status of the disease every 3 months after you stop receiving the study drug. If you are contacted by phone, each phone call should take about 5 minutes.
This is an investigational study. Abraxane is FDA approved and commercially available for the treatment of breast cancer. It is not FDA approved for the treatment of colorectal or small bowel cancer. The use of abraxane in patients with colorectal cancer or small bowel cancer is investigational.
Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.
- Being tested
- Abraxane
- Keywords
- Colorectal Cancer, Cancer of Gastrointestinal Tract, CIMP-high Colorectal Adenocarcinoma, Small Bowel Adenocarcinomas, Colorectal, Small bowel cancer, Abraxane, Nab-Paclitaxel, Paclitaxel (Protein-Bound), ABI-007
- Medical subject headings
- Colorectal Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
Also called Nab-Paclitaxel, Paclitaxel (Protein-Bound), ABI-007
220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Abraxane | Experimental | Abraxane 220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days. Receives: Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)
Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): >20% increase (absolute increase >5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) [second tumor assessment not <4 weeks from response observed]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.
Measured: Assessed at 21 day cycle; Restaging done every 3 cycles
Secondary outcomes (1)
Progression-Free Survival (PFS)
The length of time during and after the treatment a participant lives without disease progression. Time to progression functions estimated using the Kaplan-Meier method. Participants who drop out of the study included in the time to event data analysis as "censored data".
Measured: Assessed at first cycle (21 days), up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Michael Overman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730586
- Sponsor's protocol ID
- 2012-0776
- Other IDs
- NCI-2013-00077
- Status last verified
- Jan 2020
- First submitted
- 26 Oct 2012
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Abraxane in CIMP-High Colorectal Adenocarcinomas and Small Bowel Adenocarcinomas
- ClinicalTrials.gov ID
- NCT01730586
- Acronym / sponsor ID
- 2012-0776
- Keywords
- Colorectal Cancer, Cancer of Gastrointestinal Tract, CIMP-high Colorectal Adenocarcinoma, Small Bowel Adenocarcinomas, Colorectal, Small bowel cancer, Abraxane, Nab-Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Nov 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if abraxane can help to control colorectal and/or small bowel cancer. The safety of this drug will also be studied.
Abraxane is designed to block cancer cells from dividing, which may cause them to die.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive the study drug in 21-day study cycles.
You will receive abraxane by vein over about 30 minutes on Day 1 of each cycle.
Study Visits:
On Day 1 of all cycles, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and blood pressure.
- You will be asked about any drugs you may be taking and about any symptoms or side effects you may be having.
- Your performance status will be recorded.
- Blood (about 2 tablespoons) will be drawn for routine tests.
At the end of every 3rd cycle (Cycles 3, 6, 9) and so on:
°You will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease. If at any point the scans show the disease appearing to get better, you will have another scan 2 cycles later.
Length of Treatment:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if you have intolerable side effects, if the study is stopped, or if you are unable to follow study instructions.
Your participation on the study will be over after the follow-up period.
End-of-Treatment Visit:
Within 10 days after you stop taking the study drug, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and blood pressure.
- You will be asked about any drugs you may be taking and about any symptoms or side effects you may be having.
- Your performance status will be recorded.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If one has not been performed in the previous 4 weeks, you will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease.
Follow-Up:
The study staff will ask about any symptoms or side effects you may be having during the 30 days after your last dose of the study drugs. The study staff may ask you by phone or at the time of a routine clinic visit. If the study staff contacts you by phone, the phone call should last about 15-30 minutes.
If you leave the study for any reason other than the disease getting worse, you will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease every 12 weeks unless you start receiving other treatment.
The study staff will also review your medical records and/or contact you to check the status of the disease every 3 months after you stop receiving the study drug. If you are contacted by phone, each phone call should take about 5 minutes.
This is an investigational study. Abraxane is FDA approved and commercially available for the treatment of breast cancer. It is not FDA approved for the treatment of colorectal or small bowel cancer. The use of abraxane in patients with colorectal cancer or small bowel cancer is investigational.
Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abraxane | Experimental | Drug: AbraxaneAbraxane 220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient must have histologically or cytologically confirmed colorectal adenocarcinoma or small bowel adenocarcinoma
- Metastatic disease documented on diagnostic imaging studies with measurable disease per RECIST version 1.1.
- Refractory disease defined as: a) prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and anti-epidermal growth factor receptor (EGFR) therapy if Kirsten rat sarcoma (KRAS) wildtype for colorectal adenocarcinoma and; b) prior treatment with fluoropyrimidine and oxaliplatin for small bowel adenocarcinoma.
- Colorectal adenocarcinoma patients must be known to have CpG island methylator phenotype. CIMP-high phenotype will be defined as hypermethylation at 2 or more of the 6 methylation-specific PCR markers (hMLH1, P16, P14, MINT1, MINT2, and MINT31).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Key exclusion criteria (7 listed)
- Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)".
- Prior treatment with taxane therapy for either colorectal cancer or small bowel adenocarcinoma.
- Chemotherapy or any other investigational agents within 14 days of first receipt of study treatment, or major surgery within 28 days of first receipt of study treatment, or palliative radiation within 7 days of first receipt of study treatment.
- Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection.
- Pregnancy (positive pregnancy test) or lactation.
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 |
|---|---|---|
| AbraxaneAlso: Nab-Paclitaxel, Paclitaxel (Protein-Bound), ABI-007220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days. | Drug | Abraxane |
Primary outcome
Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)
Time frame: Assessed at 21 day cycle; Restaging done every 3 cycles
Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): >20% increase (absolute increase >5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) [second tumor assessment not <4 weeks from response observed]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: Assessed at first cycle (21 days), up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Michael Overman, MD principal investigator
M.D. Anderson Cancer Center
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 and Cancer of Gastrointestinal Tract, run by M.D. Anderson Cancer Center 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 10 inclusion and 7 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 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) (time frame: Assessed at 21 day cycle; Restaging done every 3 cycles). 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 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.