A Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of AZD2171 45mg Versus Placebo following 12 Weeks of Treatment in Patients with Metastatic or Recurrent Renal Cell Carcinoma who have had no Previous Anti-VEGF Therapy.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 105

Inclusion Criteria

1.Provision of informed consent
2.Males or females aged 18 years and older
3.Histological/cytological confirmation of metastatic or recurrent renal cell clear cell/adenocarcinoma
4.One or more measurable lesions at least 10mm in the longest diameter by spiral computed tomography scan or 20mm with conventional techniques (RECIST criteria)
5.WHO performance status 0-2
6.Life expectancy = 12 weeks

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous anti-VEGF therapy
2.More than one previous type of immunotherapy
3.Prior cytotoxic chemotherapy intended to treat RCC
4.Surgery scheduled within 12 weeks after entry to the study.
5.Treatment with an investigational drug within 30 days prior to the first dose of AZD2171.
6.Other concomitant anti-cancer therapy (including LHRH agonists), except steroids
7.Untreated unstable brain or meningeal metastases. Patients with radiological evidence of stable brain metastases are eligible providing that they are asymptomatic and either do not require corticosteroids or have been treated with corticosteroids, with clinical and radiological evidence of stabilisation at least 10 days after discontinuation of steroids.
8.History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of renal cell carcinoma from a target lesion.
9.Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count =1.5 x 10(to power 9)/L or platelet count =100 x 10 (to power 9)/L or requiring regular blood transfusions to maintain haemoglobin >9g/dL
10.Serum bilirubin = 1.5 x ULRR
11.ALT or AST = 2.5 x ULRR. If liver metastases are present, ALT or AST > 5 x ULRR
12.Serum creatinine > 1.5 x ULRR or a creatinine clearance of = 50mL/min calculated by Cockcroft-Gault
13.Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart unless urinary protein < 1.5g in a 24 hr period.
14.History of significant gastrointestinal impairment, as judged by the investigator, that would significantly affect the absorption of AZD2171, including the inability to swallow the tablet whole.
15.Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 in the presence or absence of a stable regimen of anti-hypertensive therapy.
16.Known hypersensitivity to AZD2171 or any of its excipients
17.Any evidence of severe uncontrolled diseases e.g. unstable or uncompensated respiratory, cardiac (including arrhythmias), hepatic or renal disease.
18.Unresolved toxicity > CTCAE grade 2 from previous anti-cancer therapy except alopecia (if applicable)
19.Mean QTc with Bazetts correction >470msec in screening ECG or history of familial long QT syndrome.
20.Significant haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks)
21.Recent (<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed
22.Pregnant or breast-feeding women or women of childbearing potential with a positive pregnancy test prior to receiving study medication
23.Known infection with hepatitis B or C or HIV
24.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
25.Previous enrolment or randomisation of treatment in the present study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials