- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01762150
Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma
November 18, 2018 updated by: Jun Guo, Peking University Cancer Hospital & Institute
Sorafenib Combined With Cisplatin and Gemcitabine for the Treatment of Patients With Advanced Renal Collecting Duct Carcinoma:A Pilot, Open Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100142
- Beijing Cancer Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
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Liaoning
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Shenyang, Liaoning, China, 110016
- Shenyang general hospital of Shenyang military command
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Shanxi
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Xi'an, Shanxi, China, 710032
- Xijing Hospital
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sorafenib combined with chemotherapy
this trial is designed single arm.
all the subjects enrolled will receive the experimental intervention,ie.
sorafenib+gemcitabine+cisplatin.
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Sorafenib 400mg BID by oral until progressed;
Other Names:
Gemcitabine: 1000mg/m2, administered by intravenous drip for 30~60min on Day 1 and 8,for 4 cycles;
Other Names:
Cisplatin: 25mg/m2, administered by intravenous drip on Day 1-3, with appropriate liquid hydration,for 4 cycles.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial
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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
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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CR:complete response PR:partial response ORR:CR+PR
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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
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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
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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
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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
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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
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the proportion of patients who don't experience progress at 3,6,9 months after enrollment
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jun Guo, MD,PHD, Peking University Cancer Hospital & Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
December 22, 2012
First Submitted That Met QC Criteria
January 4, 2013
First Posted (Estimate)
January 7, 2013
Study Record Updates
Last Update Posted (Actual)
November 20, 2018
Last Update Submitted That Met QC Criteria
November 18, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Neoplasms, Ductal, Lobular, and Medullary
- Carcinoma, Renal Cell
- Carcinoma
- Carcinoma, Ductal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protein Kinase Inhibitors
- Gemcitabine
- Cisplatin
- Sorafenib
Other Study ID Numbers
- BCH-RCC-120601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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