Phase 2
N=34
Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas
Colorectal Cancer · Cancer of Gastrointestinal Tract
Bottom Line
View on ClinicalTrials.gov: NCT01730586 ↗Enrolled (actual)
34
Serious AEs
58.8%
Results posted
Jan 2020
Primary outcome: Primary: Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) — 0; 0; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abraxane (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA) |
0; 0; 0; 2; 3; 3 | — |
| SECONDARY Progression-Free Survival (PFS) |
2.1; 3.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 =/ 18 years of age on the day of consenting to the study.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01730586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.