Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Drug: Sorafenib
* Drug: Gemcitabine
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sorafenib combined with chemotherapy<br>this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,ie. sorafenib+gemcitabine+cisplatin. | Drug: Sorafenib<br>* Sorafenib 400mg BID by oral until progressed;<br>* Other names: Nexavar;Drug: Gemcitabine<br>* Gemcitabine: 1000mg/m2, administered by intravenous drip for 30 60min on Day 1 and 8,for 4 cycles;<br>* Other names: Gemzar;Drug: Cisplatin<br>* Cisplatin: 25mg/m2, administered by intravenous drip on Day 1-3, with appropriate liquid hydration,for 4 cycles.<br>* Other names: Cis-Dichlorodiamineplatinum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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collected duct carcinoma, sorafenib