Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 3 December 2012
• Main ID: NCT00527124
• Date of registration: 07/09/2007
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
• Scientific title: A Randomized, Phase II Trial of AZD2171, Docetaxel, and Prednisone Compared to Docetaxel and Prednisone in Patients With Metastatic, Hormone Refractory Prostate Cancer
• Date of first enrolment: November 2007
• Target sample size: 104
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00527124
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Elisabeth Heath
• Affiliation: Wayne State University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical/radiologic metastases with objective evidence of disease progression by
imaging or by rising prostate-specific antigen (PSA) despite androgen deprivation
therapy

- Rising PSA must be determined based on a rising trend with 2 successive elevations at
a minimum interval of 1 week

- Meets 1 of the following criteria: Measurable disease, with any level of PSA, at
least 1 unidimensionally measurable lesion (longest diameter to be recorded) >= 20 mm
by conventional techniques or >= 10 mm by spiral CT scan, nonmeasurable disease, PSA
>= 5 ng/mL OR new areas of bony metastases on bone scan

- Castrate levels of testosterone < 50 ng/dL must be maintained and documented

- Luteinizing hormone-releasing hormone (LHRH) agonist therapy must be continued, if
required to maintain castrate levels of testosterone

- Total bilirubin normal

- Patients with radiological evidence of stable brain metastases are eligible provided
they are asymptomatic and do not require corticosteroids or have been treated with
corticosteroids and show clinical and radiological evidence of stabilization at least
10 days after discontinuation of steroids

- ECOG performance status (PS) =< 2 or Karnofsky PS 60-100%

- Life expectancy > 12 weeks

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,500/mcL

- Platelet count >= 100,000/mcL

- Histologically confirmed adenocarcinoma of the prostate

- AST and ALT =< 2.5 times upper limit of normal

- Creatinine normal OR creatinine clearance >= 60 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Proteinuria =< 1+ and urine protein:creatinine ratio =< 1.0 OR 24-hour urine protein
< 1,000 mg

- Peripheral neuropathy >= grade 2

- Uncontrolled intercurrent illness including, but not limited to, any of the
following: ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations
that would limit compliance with study requirements

- Congestive heart failure, second or third degree heart block, or recent myocardial
infarction within the past 6 months

- QTc prolongation > 500 msec OR other ECG abnormality noted within 14 days of
treatment

- New York Heart Association class III or IV cardiac disease; Class II disease
controlled with treatment and monitoring allowed

- History of poorly controlled hypertension (e.g., resting blood pressure > 150/90 mm
Hg with or without hypertensive therapy)

- History of a curatively treated malignancy with a survival prognosis of less than 5
years or concurrent malignancy except for adequately treated basal cell or squamous
cell skin cancer or carcinoma in situ

- History of significant gastrointestinal impairment, as judged by the investigator,
that would significantly affect the absorption of cediranib

- History of severe hypersensitivity reaction to docetaxel or other drugs formulated
with polysorbate 80

- Significant hemorrhage (30 mL bleeding/episode in previous 3 months) or hemoptysis (5
mL fresh blood in previous 4 weeks)

- Prior enrollment or randomization of treatment in the present study

- Patients must be off flutamide antiandrogen therapy for = 4 weeks (6 weeks for
bicalutamide or nilutamide)

- No prior chemotherapy for metastatic prostate cancer

- No major surgery within the past 14 days or a surgical incision that is not fully
healed

- No HIV-positive patients on combination antiretroviral therapy

- No conditions requiring concurrent use of drugs or biologics with proarrhythmic
potential

- No other investigational agents within 30 days prior to study enrollment

- No untreated unstable brain or meningeal metastases

- Known hypersensitivity to cediranib or any of its excipients



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Adenocarcinoma of the Prostate

Stage IV Prostate Cancer

Intervention(s)

Drug: cediranib maleate

Drug: docetaxel

Drug: prednisone

Other: immunologic technique

Other: laboratory biomarker analysis

Primary Outcome(s)

Progression-free survival rate [Time Frame: Up to 6 months]

Secondary Outcome(s)

Overall survival [Time Frame: The time from registration date until death from any cause, assessed up to 52 weeks]

Partial and complete response rate evaluated by the RECIST criteria [Time Frame: Up to 52 weeks]

Prostate-specific antigen (PSA) response and PSA control duration in accordance with the Prostate Specific Antigen Working Group [Time Frame: Up to 52 weeks]

Time to progression [Time Frame: The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks]

Secondary ID(s)

2007-015

C06CM62207

CDR0000564449

N01CA62202

NCI-2009-00174

U01CA062487

U01CA062491

Source(s) of Monetary Support

Please refer to primary and secondary sponsors