Clinical trial NCT01762150: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Keywords: collected duct carcinoma
sorafenib
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2013-01-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: progress-free survival,PFS
timeFrame: 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:
measure: adverse event, AE
timeFrame: 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 outcomes:
measure: objective response rate (ORR)
timeFrame: 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
measure: overall survival (OS)
timeFrame: 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
measure: the rate of progress-free survive
timeFrame: 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
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen university cancer center
state: Guangdong
city: Shenyang
country: China
facility: Shenyang general hospital of Shenyang military command
state: Liaoning
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Guo, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.