Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma

NCT01762150 | Completed Phase 2 DMC

• 1 other identifier: BCH-RCC-120601
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

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.

Conditions

Renal Cell Carcinoma

Keywords

collected duct carcinoma; sorafenib

Outcome Measures

Primary Outcomes (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.

  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)

• adverse event, AE

  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 (3)

• objective response rate (ORR)

  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

• 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

• the rate of progress-free survive

  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

Study Arms (1)

sorafenib combined with chemotherapy

EXPERIMENTAL

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

Drug: Sorafenib; Drug: Gemcitabine; Drug: Cisplatin

Interventions

Sorafenib DRUG

Sorafenib 400mg BID by oral until progressed;

Also known as: Nexavar

sorafenib combined with chemotherapy

Gemcitabine DRUG

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

Also known as: Gemzar

sorafenib combined with chemotherapy

Cisplatin DRUG

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

Also known as: Cis-Dichlorodiamineplatinum

sorafenib combined with chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Bayer: collaborator

Study Sites (5)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Sun Yat-sen university cancer center

Guangzhou, Guangdong, 510060, China

Location

Shenyang general hospital of Shenyang military command

Shenyang, Liaoning, 110016, China

Location

Xijing Hospital

Xi’an, Shanxi, 710032, China

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (3)

• 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.

  PMID: 17437788 BACKGROUND

• 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.

  PMID: 17215530 BACKGROUND

• 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.

  PMID: 29933095 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jun Guo, MD,PHD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of renal cancer and melanoma department

Study Record Dates

• First Submitted: December 22, 2012
• First Posted: January 7, 2013
• Study Start: June 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

CN (5)