Patient has histological confirmed residual, recurrent or metastatic EBV-positive Nasopharynx carcinoma that has failed conventional curative treatments and deemed incurable, or patient refuses further treatment with conventional methods because of associated morbidity/mortality or private reasons.
Conditions
Interventions
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
I
Sponsors
ZonMW
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient has histological confirmed residual, recurrent or metastatic nasopharyngeal carcinoma that has failed conventional curative treatments and deemed incurable, or patient refuses further treatment with conventional methods because of associated morbidity/mortality or private reasons. • Patient has EBV positive NPC • Measurable disease, according to RECIST criteria • WHO PS 0-2 • Age 18-70 years • Signed written informed consent before any study related activities are carried out • Expected adequacy of follow-up Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Active infection (infection requiring IV antibiotics), including active tuberculosis, and known and declared HIV. • Pregnancy (absence confirmed by serum or urine ß-HCG test) or lactation period • Concurrent treatment with any other anti-cancer therapy. • Class 3-4 cardiac morbidity, as defined by the New York Heart association Criteria (e.g. uncontrolled or symptomatic congestive heart failure, myocardial infarction within six months prior to the start of study, uncontrolled or symptomatic angina) and any cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. • Current active hepatic or biliary disease (with exception of Gilbert’s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) • Renal function as measured by creatinine clearance <60 ml/min • Presence of severe and/or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes mellitus, uncontrolled liver disease, including chronic viral hepatitis judged at risk of reactivation, uncontrolled active infection such as HIV infection, etc.) • Concomitant (or within 4 weeks before randomization) administration of any other experimental drug under investigation; chemotherapy or other anti-cancer therapy for the recurrence or metastatic disease; chemotherapy for initial treatment, i.e. chemoradiotherapy, is allowed. • Concurrent or previous malignancy of a different tumor type within five years of starting the study except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia • Legal incapacity • History of malabsorption syndrome or other disease that could significantly affect absorption of drugs • Systemic steroids within 2 weeks prior to study treatment • Myocardial infarction or cerebrovascular accident (CVA) within 6 months prior to study treatment • Patients who have known hypersensitivity to the study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety assessment, to assess toxicity of the combination treatment with GCb, VPA and GCV. GCb, VPA and GCV are all approved for clinical use at the proposed dosage. Compare two different doses of VPA. To explore the pharmacokinetic and pharmacodynamic profile of GCb, VPA and GCV. ;Secondary Objective: Clinical response Biological effect of GCb, VPA and GCV. Monitoring of EBV specific immune response (id est T &B-cell response) during treatment ;Primary end point(s): The primary objective is to assess toxicity of the combination treatment, i.e. GCb, VPA and GCV, by evaluation of adverse events (AE’s) serous adverse events (SAE’s) and all clinically significant changes in clinical laboratory values. Pharmacokinetic endpoints will consist of parameters such as AUC, Css, Cmax, tmax and t1/2 of i.v. Gemcitabine and oral VPA and GCV in combination | — |
Countries
Netherlands
Outcome results
None listed