Phase II escalation study of sorafenib in patients with advanced renal cell carcinoma who progressed after routine dosage of sorafenib

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-ONRC-12002088
• Date of registration: 2012-04-06
• Prospective Registration: No
• Primary sponsor: Fudan University Shanghai Cancer Center
• Public title: Phase II escalation study of sorafenib in patients with advanced renal cell carcinoma who progressed after routine dosage of sorafenib
• Scientific title: Phase II escalation study of sorafenib in patients with advanced renal cell carcinoma who progressed after routine dosage of sorafenib
• Date of first enrolment: 2011-04-06
• Target sample size: 1:50;2:50;3:20;4:20;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=7461
• Study type: Observational study
• Study design: Non randomized control
• Phase: IV (Phase IV study)

Countries of recruitment

China

Contacts

• Name: Zhang Hailiang
• Affiliation: Fudan University Shanghai Cancer Center

• Name: Ye Dingwei

Key inclusion & exclusion criteria

Inclusion criteria: 1. all patients with histologically confirmed RCC that was metastatic or unresectable and measurable according to Response Evaluation Criteria in Solid Tumors(RECIST1.0);
2. patients who was treated with routine dosage of sorafenib but failed;
3. male or female, age 18-75;
4. Patients were required to have an Eastern Cooperative Oncology Group performance status (ECOGPS) of <=2;
5. expected survival time more than 3 months;
6. absolute neutrophil count >=1.5*10^9/L, platelet count >=100*10^9/L, creatinine <=upper limit of normal, and total bilirubin <=1.5*upper limit of normal.
Exclusion criteria: 1. have been treated with anti-angiogenic therapy other than sorafenib;
2. With other malignancies (except cured basal cell skin cancer or Cervical carcinoma in situ);
3. factors which will influence oral taking of drugs, for example: bad compliance, chronic diarrhea;
4. With other serious diseases, such as: unstable heart disease, severe cerebral vascular disease;
5. severe neurological or phycological disorders;
6. Other anti-tumor treatment or drugs applied simultaneously.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

renal cell carcinoma

Intervention(s)

1:sorafenib 600mg p.o bid;2:sunitinib 50mg p.o qd;3:Everolimus 10mg p.o qd;4:Everolimus 10mg p.o qd;

Primary Outcome(s)

progression free survival;

Secondary Outcome(s)

overall survival;Objective response rate;Disease control rate;Adverse drug reaction;Quality of life;

Source(s) of Monetary Support

Fudan University Shanghai Cancer Center