Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Beijing Cancer Hospital
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Jun Guo, Beijing Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01762150
First received: December 22, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

The goal of this clinical research study is to learn the effectiveness of sorafenib combined with gemcitabine plus cisplatin in the treatment of patients with locally advanced or metastatic collecting duct carcinoma(CDC) of the kidney. The safety of each treatment will also be studied.


Condition Intervention Phase
Renal Cell Carcinoma
Drug: sorafenib+gemcitabine+cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sorafenib Combined With Cisplatin and Gemcitabine for the Treatment of Patients With Advanced Renal Collecting Duct Carcinoma:A Pilot, Open Study

Resource links provided by NLM:


Further study details as provided by Beijing Cancer Hospital:

Primary Outcome Measures:
  • progress-free survival,PFS [ Time Frame: Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until 30 June 2015 cut of date ] [ Designated as safety issue: No ]
    Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.


Secondary Outcome Measures:
  • adverse event, AE [ Time Frame: Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until 30 June 2015 cut of date ] [ Designated as safety issue: Yes ]
    Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial


Other Outcome Measures:
  • objective response rate (ORR) [ Time Frame: Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until 30 June 2015 cut of date ] [ Designated as safety issue: No ]
    CR:complete response PR:partial response ORR:CR+PR

  • overall survival (OS) [ Time Frame: Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment until 30 June 2015 cut of date ] [ Designated as safety issue: Yes ]
    Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment until 30 June 2015 cut of date

  • the rate of progress-free survive [ Time Frame: Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until 30 June 2015 cut of date ] [ Designated as safety issue: No ]
    the proportion of patients who don't experience progress at 3,6,9 months after enrollment


Estimated Enrollment: 20
Study Start Date: June 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sorafenib combined with chemotherapy
this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,ie. sorafenib+gemcitabine+cisplatin.
Drug: sorafenib+gemcitabine+cisplatin

All subjects in the experimental arm will receive sorafenib +cisplatin+gemcitabine.

Gemcitabine: 1000mg/m2, administered by intravenous drip for 30~60min on Day 1 and 8,for 4 cycles.

Cisplatin: 25mg/m2, administered by intravenous drip on Day 1-3, with appropriate liquid hydration,for 4 cycles.

Other Names:
  • Nexavar is the brand name of sorafenib;
  • Gemzar is the brand name of gemcitabine;
  • cis-Dichlorodiamineplatinum for the other name of cisplatin

Detailed Description:

Collecting duct carcinoma(CDC) of the kidney is a rare and aggressive neoplasm of the distal collecting tubules for which there is no established treatment. Since the histology of collecting duct carcinoma is similar to that of urothelial carcinoma, a prospective phase II trial in France(2007) studied gemcitabine plus cisplatin as the first-line treatment of advanced CDC, resulting an effective rate of 26%. The targeted drugs can produce definite efficacy on renal clear cell carcinoma, but the data on targeted drugs for the treatment of renal advanced collecting duct carcinoma is limited. We sponsored this study based on the assumption that targeted drugs combined with chemotherapy can produce additive, positive effects in CDC.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age≥18 years, ≤70 years, male or female;
  • Advanced collecting duct carcinoma of the kidney is diagnosed histologically or pathologically ;
  • Have not received anti-angiogenesis targeted drug therapy and systemic chemotherapy;
  • Have at least one measurable tumor lesion (Response Evaluation Criteria In Solid Tumors);
  • Eastern Cooperative Oncology Group(ECOG) performance scale is 0 or 1;
  • The expected life span is ≥12 weeks;
  • No contraindications for chemotherapy, with enough liver function and renal function and normal ECG recording.Peripheral hemogram: neutrophil≥1.5×109/L, Plt≥100×109/L, Hgb≥90 g/L;Renal function: serum creatinine≤1.5 folds the upper limit of normal (ULN); For patients with non-metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤2.5 ULN, For patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 ULN;
  • The patients participate voluntarily and have signed the informed consent form.

Exclusion Criteria:

  • Pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures;
  • Patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds;
  • Past history of serious heart diseases, including: cardiac function classification ≥NYHA class II, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension;
  • Patients with a history of HIV infection or active phase of chronic hepatitis B/C;
  • negative imaging examination result 4 weeks prior to enrollment);
  • Epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs);
  • A history of allogeneic organ transplantation;
  • Patients with evidence of hemorrhagic constitution or a past history of hemorrhage;
  • Patients currently receiving renal dialysis;
  • Past or present concomitant tumors with the primary lesions or histological characteristics different from the tumors evaluated in this study, excluding other tumor cured longer than 3 years before enrollment;
  • Patients participating in other clinical trials simultaneously;
  • Other conditions unsatisfying the inclusion criteria in the investigator's opinions.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762150

Contacts
Contact: Xinan Sheng, MD 0086-10-88196951 doctor_sheng@126.com

Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Xinan Sheng, MD    0086-10-88196951    doctor_sheng@126.com   
Principal Investigator: Jun Guo, MD,PHD         
Sub-Investigator: Xinan Sheng, MD         
China, Guangdong
Sun Yat-sen university cancer center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Fangjian Zhou, MD    0086-20-87343088    zhoufj@sysucc.org.cn   
Principal Investigator: Fangjian Zhou, MD         
China, Liaoning
Shenyang general hospital of Shenyang military command Recruiting
Shenyang, Liaoning, China, 110016
Contact: Xiaodong Xie, MD    0086-24-23892351    xiexiaodong2010@yahoo.com.cn   
Principal Investigator: Xiaodong Xie, MD         
China, Shanxi
Xijing Hospital Recruiting
Xi'an, Shanxi, China, 710032
Contact: Jianlin Yuan, MD    0086-29-84774114    jianlin@fmmu.edu.cn   
Principal Investigator: Jianlin Yuan, MD         
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Qiang Wei, MD    0086-28-85422286    wq933@hotmail.com   
Principal Investigator: Qiang Wei, MD         
Sponsors and Collaborators
Beijing Cancer Hospital
Bayer
Investigators
Principal Investigator: Jun Guo, MD,PHD Beijing Cancer Hospital
  More Information

Publications:
Responsible Party: Jun Guo, Director of renal cancer and melanoma department, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01762150     History of Changes
Other Study ID Numbers: BCH-RCC-120601
Study First Received: December 22, 2012
Last Updated: January 23, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Cancer Hospital:
advanced,renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Carcinoma
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Sorafenib
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 16, 2014