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Renal Cell CarcinomaPhase 2NCT01762150

Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma

A Phase 2 study testing Sorafenib, Gemcitabine and Cisplatin in people with Renal Cell Carcinoma, run by Peking University Cancer Hospital & Institute at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Sorafenib, Gemcitabine and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
5 sitesChina
Study dates
Jun 2011to Jun 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • West China Hospital

    Chengdu, Sichuan, 610041

  • Sun Yat-sen university cancer center

    Guangzhou, Guangdong, 510060

  • Shenyang general hospital of Shenyang military command

    Shenyang, Liaoning, 110016

  • Xijing Hospital

    Xi’an, Shanxi, 710032

Other trials in China

About this study

Official title: 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.

Read the 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.

Keywords
collected duct carcinoma, sorafenib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SorafenibDrug

    Also called Nexavar

    Sorafenib 400mg BID by oral until progressed;

  • GemcitabineDrug

    Also called Gemzar

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

  • CisplatinDrug

    Also called Cis-Dichlorodiamineplatinum

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

Study groups in NCT01762150
Study groupRoleWhat they receive
sorafenib combined with chemotherapyExperimentalthis trial is designed single arm. all the subjects enrolled will receive the experimental intervention,ie. sorafenib+gemcitabine+cisplatin.
Receives: Drug: Sorafenib; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (1)

  1. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2013 (estimated)
  2. Study startJun 2011
  3. Primary completionDec 2016
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01762150
Sponsor's protocol ID
BCH-RCC-120601
Status last verified
Nov 2018
First submitted
22 Dec 2012
Last updated
20 Nov 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 17437788

  • 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.

    PubMed 17215530

  • 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.

    PubMed 29933095

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib, Gemcitabine and Cisplatin in people with Renal Cell Carcinoma, run by Peking University Cancer Hospital & Institute at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01762150, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.

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