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Decitabine Combined With Oxaliplatin in Patients With Advanced Renal Cell Carcinoma

Primary Purpose

Metastatic Renal Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Decitabine; Oxaliplatin

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring renal cell carcinoma, chemotherapy, decitabine, oxaliplatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination of decitabine with oxaliplatin treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Overall survival

Overall survival is defined as the time from randomization to the date of death.

Full Information

NCT ID

NCT04049344

First Posted

August 2, 2019

Last Updated

August 7, 2019

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04049344

Brief Title

Decitabine Combined With Oxaliplatin in Patients With Advanced Renal Cell Carcinoma

Official Title

Phase II Multicenter Open-Label Single-Arm Study of Decitabine Combined With Oxaliplatin in Patients With Relapsed/Metastatic Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 15, 2019 (Anticipated)

Primary Completion Date

June 30, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Renal Cell Carcinoma

Keywords

renal cell carcinoma, chemotherapy, decitabine, oxaliplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combination of decitabine with oxaliplatin treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Decitabine; Oxaliplatin

Intervention Description

Primary Outcome Measure Information:

Title

Progression free survival

Description

Time Frame

Six months after randomization

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival is defined as the time from randomization to the date of death.

Time Frame

Two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wang Hua, Ph.D.; M.D.

Phone

+86-571-8812-8031

Ext

8031

wanghua@zjcc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

He Yedie, M.D.

Phone

+86-571-8812-8031

Ext

8031

525507831@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wang Hua, Ph.D.; M.D.

Organizational Affiliation

Zhejiang Cancer Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wang Hua, Ph.D.;M.D.

Phone

+86-571-8812-8031

Ext

8031

wanghua@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

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Decitabine Combined With Oxaliplatin in Patients With Advanced Renal Cell Carcinoma

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