Metastatic Renal Cell CarcinomaPhase 2NCT04049344
Decitabine Combined With Oxaliplatin in Patients With Advanced Renal Cell Carcinoma
A Phase 2 study testing Decitabine; Oxaliplatin in people with Metastatic Renal Cell Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Decitabine; Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2019to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Wang Hua, Ph.D.;M.D., +86-571-8812-8031 ext. 8031, wanghua@zjcc.org.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Decitabine; Oxaliplatin
- Keywords
- renal cell carcinoma, chemotherapy, decitabine, oxaliplatin
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decitabine; OxaliplatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Combination of decitabine with oxaliplatin treatment | Experimental | 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. Receives: Drug: Decitabine; Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
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).
Measured: Six months after randomization
Secondary outcomes (1)
Overall survival
Overall survival is defined as the time from randomization to the date of death.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start15 Aug 2019 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Hua, Ph.D.; M.D., Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049344
- Sponsor's protocol ID
- CHUCAS-025
- Status last verified
- Jul 2019
- First submitted
- 2 Aug 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Open-Label Single-Arm Study of Decitabine Combined With Oxaliplatin in Patients With Relapsed/Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04049344
- Acronym / sponsor ID
- CHUCAS-025
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- renal cell carcinoma, chemotherapy, decitabine, oxaliplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 15 Aug 2019 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of decitabine with oxaliplatin treatment | Experimental | Drug: Decitabine; OxaliplatinPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decitabine; OxaliplatinPatients 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. | Drug | Combination of decitabine with oxaliplatin treatment |
Primary outcome
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).
1 secondary outcome
Overall survival
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Hua, Ph.D.; M.D. study chair
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decitabine; Oxaliplatin in people with Metastatic Renal Cell Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Hua, Ph.D.; M.D. (+86-571-8812-8031 ext. 8031, wanghua@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Six months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.