Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01730586
First received: October 26, 2012
Last updated: May 21, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Cancer of Gastrointestinal Tract |
Drug: Abraxane |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Abraxane in CIMP-High Colorectal Adenocarcinomas and Small Bowel Adenocarcinomas |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma [ Time Frame: 21 days ] [ Designated as safety issue: No ]Sample size of 15 patients with CIMP-high required to demonstrate a response rate of 20% using a binomial one-sample test with a two-sided alpha of 0.025 and power of 91%. For second disease group, 10 small intestinal adenocarcinomas patients enrolled to test if a null hypothesis of ≤1% response rate is different from an alternative hypothesis of a response rate of 20% using a binomial one-sample test with a two-sided alpha of 0.025 and power of 0.85. A Bonferroni's correction used to account for the multiple testing (overall alpha=0.05/2 tests). Pearson chi-square (or Fisher's exact test) or t-test (or Wilcoxon rank test) used to determine differences between responder and non-responders.
Secondary Outcome Measures:
- Progression-Free Survival [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]Overall survival and time to progression functions will be estimated using the Kaplan-Meier method. Patients who drop out of the study will be included in the time to event data analysis as "censored data". For progression-free survival as a binary endpoint, the intent-to-treat analysis will be performed using all available patients. A two-sided log-rank test will be used to assess the differences of time to events between groups.
| Estimated Enrollment: | 25 |
| Study Start Date: | November 2012 |
| Estimated Primary Completion Date: | November 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Abraxane
Abraxane 220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.
|
Drug: Abraxane
220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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-EGFR therapy if 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 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.
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730586
Contacts
| Contact: Michael Overman, MD | 713-745-4317 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
| Principal Investigator: | Michael Overman, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01730586 History of Changes |
| Other Study ID Numbers: | 2012-0776 |
| Study First Received: | October 26, 2012 |
| Last Updated: | May 21, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Colorectal Neoplasms Gastrointestinal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Intestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013