Decitabine Combined With Oxaliplatin in Patients With Advanced Renal Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    25
  • sponsor
    Zhejiang Cancer Hospital
Updated on 23 January 2021
platelet count
cancer
decitabine
myocardial infarction
oxaliplatin
neutrophil count
advanced renal cell carcinoma

Summary

The investigators reported previously that epigenetic activation of organic cation transporter (OCT2) by decitabine sensitizes RCC cells to oxaliplatin both in vitro and in xenografts. The objective of this phase II clinical trial is to investigate the efficacy and safety of sequential combination therapy with decitabine and oxaliplatin in patients with relapsed/metastatic renal cell carcinoma who progressed on standard of care.

Description

CHUCAS-025 (Cancer Hospital, University of Chinese Academy of Sciences) is a phase II trial conducted at 3 investigative centres in the Zhejiang Province, China. Eligible patients are 18 to 75 years old with relapsed/metastatic renal cell carcinoma progressed on standard of care. Patients receive Decitabine 10 mg/day for 5 consecutive days (d1-5) plus Oxaliplatin 75mg/m2 2-week-cycle (d6, d20) within 4 weeks. One cycle is defined as 4 weeks of treatment and total of 6 cycles are designed for patients. Patients who experienced unacceptable toxicities or clinical or documented progressive disease are discontinued from the study. The duration of any objective response is measured from the date the initial response is observed to the date that disease progression is observed. Patients receiving 2 cycles of treatment are considered evaluable for response using Response Evaluation Criteria in Solid Tumors (RECIST). Disease assessment by the investigator include response assessment and diagnostic imaging and measuring of target lesions. All patients receive computed tomography and/or magnetic resonance imaging scans for assessing disease status. All patients were followed up until death from any cause.

Details
Condition Metastatic Renal Cell Carcinoma, Metastatic Kidney Cancer
Treatment Decitabine; Oxaliplatin
Clinical Study IdentifierNCT04049344
SponsorZhejiang Cancer Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Metastatic Renal Cell Carcinoma?
Do you have any of these conditions: Metastatic Kidney Cancer or Metastatic Renal Cell Carcinoma?
Age: 18 ~75 years old
Patients who are diagnosed pathologically with relapsed/metastatic renal cell carcinoma have a disease progression on standard of care
Performance status: Eastern Cooperative Oncology Group performance status 2
Life expectancy more than 3 months
Patients have adequate organ function, accord with following criteria: A. blood routine: Hemoglobin90g/L, absolute neutrophil count1.5109/L, platelet count 80109/L; B. Biochemical tests: total bilirubin is less than 1.5 times upper limit of normal, alanine aminotransferase and aspartate aminotransferase are less than 2.5 times upper limit of normal; C. creatinine less than 1.25 times upper limit of normal
Patients agree to use adequate contraception in the period of trial and need negative pregnancy test in childbearing potential women
Patients agree to receive treatment with epigenetic drugs
Participant sign an institutional review board-approved, protocol-specific informed consent form in accordance with institutional guidelines
Exclude criteria
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods
Organs failure
ECOG >2\
Serious/active infection
Autoimmune disorders or immunodeficiency diseases
Patients with allergic constitution, or other disease need take drugs of immunosuppressant or corticosteroids
Uncontrolled hypertension
Myocardial ischemia (more than grade II ) or myocardial infarction or uncontrolled arrhythmia
Cardiac insufficiency of grade III to IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) <50%
Coagulation disorders, tendency of haemorrhage, undergoing thrombolytic or anticoagulant therapy
Unhealed wounds, or fractures
With a history of psychotropic drug abuse or mental disorders
Prior systemic therapies with any antitumor agents within 4 weeks
With other uncurable cancers simultaneously
Clear my responses

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