Overview
Azacitidine and CAPOX in Metastatic Colorectal Cancer
Status:
Completed
Completed
Trial end date:
2016-11-01
2016-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The goal of the Phase I portion of this study is to find the highest tolerable dose of azacitidine combined with capecitabine and oxaliplatin (CAPOX) that can be given to patients with metastatic colorectal cancer. The goal of the Phase II portion of this study is to learn if azacitidine, given in combination with CAPOX, can help to control metastatic colorectal cancer. The safety of this drug combination will also be studied.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
M.D. Anderson Cancer CenterCollaborator:
CelgeneTreatments:
Azacitidine
Capecitabine
Decitabine
Oxaliplatin
Criteria
Inclusion Criteria:1. Phase I: Patient must have histologically or cytologically confirmed colorectal
adenocarcinoma with metastatic disease documented on diagnostic imaging studies.
Disease may be measurable or non-measurable as per RECIST version 1.1.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
3. For patients on full-dose low-molecular weight anticoagulation, no active bleeding or
pathological condition that carries a high risk of bleeding (e.g., tumor involving
major vessels or know varices) is allowed.
4. Serum bilirubin levels laboratory (ULN)
5. Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) levels
6. Serum creatinine levels
7. Absolute neutrophil count of >/=1,500/mm^3 (ie, >/=1.5 x 10^9/L by International Units
[IU]).
8. Platelet count >/=100,000/mm^3 (IU: ≥100 x 10^9/L).
9. Hemoglobin value of >/=9.0 g/dL.
10. No limit to number of prior therapies.
11. Women of childbearing potential must have a negative serum pregnancy test and must be
advised to avoid becoming pregnant. Men should be advised to not father a child while
receiving treatment. Sexually active women of childbearing potential and men must use
an effective method of birth control during the course of the study, in a manner such
that risk of failure is minimized.
12. Patient must be refractory to treatment with 5-FU (either intravenous 5-FU or as the
oral prodrug, capecitabine) and oxaliplatin, defined as previous clinical or
radiographic progression on or within 3 months of treatment with 5-FU and oxaliplatin.
There is no limit to the number of prior lines of therapy.
13. Phase II: Patient must have histologically or cytologically confirmed colorectal
adenocarcinoma with measurable metastatic disease documented on diagnostic imaging
studies by RECIST version 1.1 criteria
14. Phase II: Patient must be known to have CpG island methylator phenotype.
Exclusion Criteria:
1. Patients with known brain metastases or carcinomatous meningitis
2. Patients unable to swallow oral medications or with gastrointestinal disorders that
might interfere with proper absorption of oral drugs.
3. Known dihydropyrimidine (DPD) deficiency
4. Grade 3 or more peripheral neuropathy
5. 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.
6. 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.
7. Known or suspected hypersensitivity to azacitidine or mannitol
8. Pregnant or breast feeding
9. Because of the interaction between coumadin and capecitabine patients taking
therapeutic doses of coumarin-derivative anticoagulants, are not eligible. Low-dose
Coumadin (e.g. 1 mg PO per day) in patients with in-dwelling venous access devices is
allowed but increased frequency of international normalized ratio (INR) monitoring is
recommended.
10. Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.