Status:
UNKNOWN
Preoperative Valproic Acid and Radiation Therapy for Rectal Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to first determine the maximum tolerated dose of capecitabine given alone or in combination with valproic acid during preoperative short-course radiotherapy (Phase 1). The...
Eligibility Criteria
Inclusion
- • Patients with histologically confirmed diagnosis of adenocarcinoma of rectum falling into one of the following categories: T2N0 located at \<2 cm from anal verge T2N1 or T3N0-N1, located at \>5 cm and \<12 cm from anal verge and infiltration of perirectal fat up to a distance of 1 mm from mesorectal fascia (MRF) evaluated by MRI.
- Age ≥18 and ≤ 70
- ECOG Performance Status ≤1
- Effective contraception for both male and female patients if the risk of conception exist
- Signed written informed consent
Exclusion
- Any previous treatment for rectal cancer
- Previous pelvic radiotherapy
- Presence of metastatic disease
- Recurrent rectal tumor
- Patient with Familial Adenomatosis Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC)
- History of inflammatory bowel disease or active 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.
- Neutrophils \< 2000/mm3 or platelets \< 100.000/ mm3 or haemoglobin \<9 gr/dl.
- Creatinine levels indicating renal clearance of \<50 ml/min
- GOT and/or GPT \> 2.5 time the UNL and/or bilirubin \>1.5 time the upper-normal limits (UNL)
- 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.
- 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.
- Patients with long QT-syndrome or QTc interval duration \> 480 msec or concomitant medication with drugs prolonging QTc (see list in the appendix)
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- HIV positive patients
- Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
- 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.
- Concurrent uncontrolled medical conditions that might contraindicate study drugs.
- Major surgical procedure, within 28 days prior to study treatment start.
- Pregnant or lactating women.
- 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.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT01898104
Start Date
May 1 2012
End Date
April 1 2024
Last Update
March 24 2023
Active Locations (1)
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1
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Italy