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Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma

Primary Purpose

Renal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sorafenib
Gemcitabine
Cisplatin
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring collected duct carcinoma, sorafenib

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Cancer Hospital
  • Sun Yat-sen university cancer center
  • Shenyang general hospital of Shenyang military command
  • Xijing Hospital
  • West China Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sorafenib combined with chemotherapy

Arm Description

this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,ie. sorafenib+gemcitabine+cisplatin.

Outcomes

Primary Outcome Measures

progress-free survival,PFS
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
Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial

Full Information

First Posted
December 22, 2012
Last Updated
November 18, 2018
Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01762150
Brief Title
Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma
Official Title
Sorafenib Combined With Cisplatin and Gemcitabine for the Treatment of Patients With Advanced Renal Collecting Duct Carcinoma:A Pilot, Open Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
collected duct carcinoma, sorafenib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sorafenib combined with chemotherapy
Arm Type
Experimental
Arm Description
this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,ie. sorafenib+gemcitabine+cisplatin.
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar
Intervention Description
Sorafenib 400mg BID by oral until progressed;
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine: 1000mg/m2, administered by intravenous drip for 30~60min on Day 1 and 8,for 4 cycles;
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Cis-Dichlorodiamineplatinum
Intervention Description
Cisplatin: 25mg/m2, administered by intravenous drip on Day 1-3, with appropriate liquid hydration,for 4 cycles.
Primary Outcome Measure Information:
Title
progress-free survival,PFS
Description
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.
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
Secondary Outcome Measure Information:
Title
adverse event, AE
Description
Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial
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
Other Pre-specified Outcome Measures:
Title
objective response rate (ORR)
Description
CR:complete response PR:partial response ORR:CR+PR
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
Title
overall survival (OS)
Description
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
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
Title
the rate of progress-free survive
Description
the proportion of patients who don't experience progress at 3,6,9 months after enrollment
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Guo, MD,PHD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Sun Yat-sen university cancer center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Shenyang general hospital of Shenyang military command
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17437788
Citation
Oudard S, Banu E, Vieillefond A, Fournier L, Priou F, Medioni J, Banu A, Duclos B, Rolland F, Escudier B, Arakelyan N, Culine S; GETUG (Groupe d'Etudes des Tumeurs Uro-Genitales). Prospective multicenter phase II study of gemcitabine plus platinum salt for metastatic collecting duct carcinoma: results of a GETUG (Groupe d'Etudes des Tumeurs Uro-Genitales) study. J Urol. 2007 May;177(5):1698-702. doi: 10.1016/j.juro.2007.01.063.
Results Reference
background
PubMed Identifier
17215530
Citation
Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. doi: 10.1056/NEJMoa060655. Erratum In: N Engl J Med. 2007 Jul 12;357(2):203.
Results Reference
background
PubMed Identifier
29933095
Citation
Sheng X, Cao D, Yuan J, Zhou F, Wei Q, Xie X, Cui C, Chi Z, Si L, Li S, Mao L, Lian B, Tang B, Yan X, Wang X, Kong Y, Dai J, Bai X, Zhou L, Guo J. Sorafenib in combination with gemcitabine plus cisplatin chemotherapy in metastatic renal collecting duct carcinoma: A prospective, multicentre, single-arm, phase 2 study. Eur J Cancer. 2018 Sep;100:1-7. doi: 10.1016/j.ejca.2018.04.007. Epub 2018 Jun 19.
Results Reference
derived
Links:
URL
http://meetinglibrary.asco.org/content/127656-144
Description
A pilot, open-label phase II study of sorafenib combined with cisplatin plus gemcitabine for the treatment of patients with advanced renal collecting duct carcinoma.

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Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma

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