Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title:

Sorafenib Combined With Cisplatin and Gemcitabine for the Treatment of Patients With Advanced Renal Collecting Duct Carcinoma:A Pilot, Open Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762150
• Other study ID #: BCH-RCC-120601
• Status: Completed
• Phase: Phase 2
• Start date: June 2011
• Est. completion date: June 2018

Study information

• Verified date: November 2018
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ductal
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Sorafenib
Sorafenib 400mg BID by oral until progressed;
• Gemcitabine
Gemcitabine: 1000mg/m2, administered by intravenous drip for 30~60min on Day 1 and 8,for 4 cycles;
• Cisplatin
Cisplatin: 25mg/m2, administered by intravenous drip on Day 1-3, with appropriate liquid hydration,for 4 cycles.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	West China Hospital	Chengdu	Sichuan
China	Sun Yat-sen university cancer center	Guangzhou	Guangdong
China	Shenyang general hospital of Shenyang military command	Shenyang	Liaoning
China	Xijing Hospital	Xi'an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Cancer Hospital	Bayer

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203. — View 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-Génitales). 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-Génitales) study. J Urol. 2007 May;177(5):1698-702. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	objective response rate (ORR)	CR:complete response PR:partial response ORR:CR+PR	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	overall survival (OS)	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 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
Other	the rate of progress-free survive	the proportion of patients who don't experience progress at 3,6,9 months after enrollment	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
Primary	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.	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	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	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

External Links

•   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.