Overview

This trial is active, not recruiting.

Condition renal cell carcinoma
Treatments sorafenib, gemcitabine, cisplatin
Phase phase 2
Targets PDGF, RAF, VEGF, FLT-3, KIT
Sponsor Beijing Cancer Hospital
Collaborator Bayer
Start date June 2011
End date December 2016
Trial size 26 participants
Trial identifier NCT01762150, BCH-RCC-120601

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,ie. sorafenib+gemcitabine+cisplatin.
sorafenib Nexavar
Sorafenib 400mg BID by oral until progressed;
gemcitabine Gemzar
Gemcitabine: 1000mg/m2, administered by intravenous drip for 30~60min on Day 1 and 8,for 4 cycles;
cisplatin Cis-Dichlorodiamineplatinum
Cisplatin: 25mg/m2, administered by intravenous drip on Day 1-3, with appropriate liquid hydration,for 4 cycles.

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Sorafenib Combined With Cisplatin and Gemcitabine for the Treatment of Patients With Advanced Renal Collecting Duct Carcinoma:A Pilot, Open Study
Principal investigator Jun Guo, MD,PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Beijing Cancer Hospital.