- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04049344
Decitabine Combined With Oxaliplatin in Patients With Advanced Renal Cell Carcinoma
August 7, 2019 updated by: Zhejiang Cancer Hospital
Phase II Multicenter Open-Label Single-Arm Study of Decitabine Combined With Oxaliplatin in Patients With Relapsed/Metastatic Renal Cell Carcinoma
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wang Hua, Ph.D.; M.D.
- Phone Number: 8031 +86-571-8812-8031
- Email: wanghua@zjcc.org.cn
Study Contact Backup
- Name: He Yedie, M.D.
- Phone Number: 8031 +86-571-8812-8031
- Email: 525507831@qq.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Wang Hua, Ph.D.;M.D.
- Phone Number: 8031 +86-571-8812-8031
- Email: wanghua@zjcc.org.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria
- 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: Hemoglobin≥90g/L, absolute neutrophil count≥1.5×109/L, platelet count ≥ 80×109/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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Combination of decitabine with oxaliplatin treatment
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: Six months after randomization
|
Progression free survival is defined as the time from randomization to first documented RECIST-defined tumor progression or death from any cause.
Disease assessments are performed with the use of computed tomography or magnetic resonance imaging at baseline, every 8 weeks for the first year, and then every 12 weeks until disease progression or discontinuation of treatment.
Imaging data were evaluated by the investigator to assess tumor response (according to RECIST version).
|
Six months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: Two years
|
Overall survival is defined as the time from randomization to the date of death.
|
Two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Wang Hua, Ph.D.; M.D., Zhejiang Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
August 15, 2019
Primary Completion (ANTICIPATED)
June 30, 2021
Study Completion (ANTICIPATED)
December 31, 2021
Study Registration Dates
First Submitted
August 2, 2019
First Submitted That Met QC Criteria
August 7, 2019
First Posted (ACTUAL)
August 8, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 8, 2019
Last Update Submitted That Met QC Criteria
August 7, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Decitabine
- Oxaliplatin
Other Study ID Numbers
- CHUCAS-025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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