Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma

P

Peking University Cancer Hospital & Institute

Status and phase

Completed
Phase 2

Conditions

Renal Cell Carcinoma

Treatments

Drug: Gemcitabine
Drug: Cisplatin
Drug: Sorafenib

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01762150
BCH-RCC-120601

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

sorafenib combined with chemotherapy
Experimental group
Description:
this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,ie. sorafenib+gemcitabine+cisplatin.
Treatment:
Drug: Sorafenib
Drug: Cisplatin
Drug: Gemcitabine

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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