Recruitment

Recruitment Status
Recruiting

Exclusion Criterias

Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
GOT and/or GPT > 2.5 time the UNL and/or bilirubin >1.5 time the upper-normal limits (UNL)
Patient with Familial Adenomatosis Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC)
...
Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
GOT and/or GPT > 2.5 time the UNL and/or bilirubin >1.5 time the upper-normal limits (UNL)
Patient with Familial Adenomatosis Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC)
Creatinine levels indicating renal clearance of <50 ml/min
Major surgical procedure, within 28 days prior to study treatment start.
Known or suspected hypersensitivity to any of the study drugs.
Patient who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid.
Previous pelvic radiotherapy
Presence of metastatic disease
History of inflammatory bowel disease or active disease
Significant cardiovascular comorbidity (e.g. myocardial infarction, superior vena cava [SVC] syndrome, patients with an ejection fraction of <50%) or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
Women of childbearing potential with either a positive or no pregnancy test at baseline (NB. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
Any concurrent malignancy except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of cervix uteri. Patients with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial.
Concurrent uncontrolled medical conditions that might contraindicate study drugs.
Recurrent rectal tumor
Pregnant or lactating women.
Patients with long QT-syndrome or QTc interval duration > 480 msec or concomitant medication with drugs prolonging QTc (see list in the appendix)
History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia.
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Neutrophils < 2000/mm3 or platelets < 100.000/ mm3 or haemoglobin <9 gr/dl.
HIV positive patients
Any previous treatment for rectal cancer

Summary

Conditions
Colorectal Cancer
Type
Interventional
Phase
Phase 1 & Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Exclusion Criterias

Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
GOT and/or GPT > 2.5 time the UNL and/or bilirubin >1.5 time the upper-normal limits (UNL)
Patient with Familial Adenomatosis Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC)
...
Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
GOT and/or GPT > 2.5 time the UNL and/or bilirubin >1.5 time the upper-normal limits (UNL)
Patient with Familial Adenomatosis Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC)
Creatinine levels indicating renal clearance of <50 ml/min
Major surgical procedure, within 28 days prior to study treatment start.
Known or suspected hypersensitivity to any of the study drugs.
Patient who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid.
Previous pelvic radiotherapy
Presence of metastatic disease
History of inflammatory bowel disease or active disease
Significant cardiovascular comorbidity (e.g. myocardial infarction, superior vena cava [SVC] syndrome, patients with an ejection fraction of <50%) or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
Women of childbearing potential with either a positive or no pregnancy test at baseline (NB. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
Any concurrent malignancy except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of cervix uteri. Patients with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial.
Concurrent uncontrolled medical conditions that might contraindicate study drugs.
Recurrent rectal tumor
Pregnant or lactating women.
Patients with long QT-syndrome or QTc interval duration > 480 msec or concomitant medication with drugs prolonging QTc (see list in the appendix)
History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia.
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Neutrophils < 2000/mm3 or platelets < 100.000/ mm3 or haemoglobin <9 gr/dl.
HIV positive patients
Any previous treatment for rectal cancer

Locations

Napoli
Napoli

Tracking Information

NCT #
NCT01898104
Collaborators
Not Provided
Investigators
  • Principal Investigator: Antonio Avallone, M.D. National Cancer Institute, Naples
  • Antonio Avallone, M.D. National Cancer Institute, Naples