Open-label, single-center phase I study to evaluate first signs of efficacy and to confirm the safety and tolerability of a decitabine safe-dose treatment in two strata of patients with HPV induced anogenital and head and neck cancers (Stratum 1: patients with high rist for disease recurrence; Stratum 2: patients with failure of standard therapy). The study is expected to enroll 18 patients overall (9 patients in each stratum). The duration of the trial for each patient is expected to be 6 months (two 28 day cycles of study treatment plus four months of additional follow-up). The overall duration of the trial is expected to be approximately 42 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Intravenous (i.v.) infusion of 20 mg/m2 over 1 hour repeated daily for 5 days starting on day 1. Single repetition of cycle on day 29.
UKHD, Klinik für RadioOnkologie und Strahlentherapie
Heidelberg, Germany
Incidence of dose limiting toxicities (DLT)
The primary objective of the study is to evaluate the safety and tolerability of decitabine treatment in two strata of patients with HPV-induced anogenital and head and neck cancer. Primary endpoint is the incidence of dose limiting toxicities (DLT) during the first two cycles of study treatment (up to day 56). DLT will be assessed and managed independently for both strata.
Time frame: 56 days
Overall Response Rate
The Overall Response Rate (or Objective Response Rate) is defined as the proportion of patients achieving a complete (CR) or partial (PR) response in their overall response assessment according to RECIST v1.1 measured at the 6 months staging vs baseline.
Time frame: 6 months
Disease Control Rate (DCR)
The Disease Control Rate (DCR) is defined as the proportion of patients achieving stable disease or a better outcome (CR, PR, SD) in their overall response assessment according to RECIST v1.1 measured at the 6 months staging vs baseline.
Time frame: 6 months
Quality of Life
Quality-of-Life (QoL) will be assessed by the EORTC Quality of Life Core Questionnaire (QLQ30), supplemented by information on self-assessed concomitant diseases and demographics. QoL will be assessed at baseline, and at week 3, 5, 8 and 24 (EOS)
Time frame: week 3, 5, 8 and 24
Overall Survival (OS)
OS is defined as the time from admission to the study until death from any cause. Patients who are alive at the end of the study are censored on the day of last contact.
Time frame: from admission until Last Patient Last Visit (LPLV), assessed ≥ 6 months
Progression-free Survival (PFS)
PFS is defined as the time from admission to the study until progression of disease or death from any cause, whichever occurs first. Patients who are alive and did not have progression of disease at the end of the study are censored on the day of last contact.
Time frame: from admission until Last Patient Last Visit (LPLV), assessed ≥ 6 months
Overall Response Rate
The ORR-3m is defined as the proportion of patients achieving a complete (CR) or partial (PR) response in their overall response assessment according to RECIST v1.1 measured at the 3 months staging vs baseline.
Time frame: 3 months
Disease Control Rate
The DCR-3m is defined as the proportion of patients achieving stable disease or a better outcome (CR, PR, SD) in their overall response assessment according to RECIST v1.1 measured at the 3 months staging vs baseline.
Time frame: 3 months
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