Decitabine Combined With Oxaliplatin in Patients With Advanced Renal Cell Carcinoma

NCT04049344 | Unknown Phase 2

• 1 other identifier: CHUCAS-025
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

renal cell carcinoma; chemotherapy; decitabine; oxaliplatin

Outcome Measures

Primary Outcomes (1)

• 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).

  Six months after randomization

Secondary Outcomes (1)

• Overall survival

  Two years

Study Arms (1)

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.

Drug: Decitabine; Oxaliplatin

Interventions

Decitabine; Oxaliplatin DRUG

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.

Combination of decitabine with oxaliplatin treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Decitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Coordination Complexes

Study Officials

• Wang Hua, Ph.D.; M.D.

  Zhejiang Cancer Hospital

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+86-571-8812-8031; wanghua@zjcc.org.cn

He Yedie, M.D.

CONTACT

+86-571-8812-8031; 525507831@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 8, 2019
• Study Start: August 15, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: August 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)