Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas
Phase II Study of Abraxane in CIMP-High Colorectal Adenocarcinomas and Small Bowel Adenocarcinomas
2 other identifiers
interventional
34
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 colorectal-cancer
Started Nov 2012
Typical duration for phase_2 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedFirst Posted
Study publicly available on registry
November 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
January 18, 2020
CompletedJanuary 18, 2020
January 1, 2020
3.8 years
October 26, 2012
May 2, 2019
January 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Assessed at 21 day cycle; Restaging done every 3 cycles
Secondary Outcomes (1)
Progression-Free Survival (PFS)
Assessed at first cycle (21 days), up to 12 months
Study Arms (1)
Abraxane
EXPERIMENTALAbraxane 220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.
Interventions
220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Celgenecollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael Overman, Associate Professor, GI Medical Oncology
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Overman, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2012
First Posted
November 21, 2012
Study Start
November 1, 2012
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
January 18, 2020
Results First Posted
January 18, 2020
Record last verified: 2020-01