Exemestane With or Without Bicalutamide in Treating Patients With Stage IV Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00031889
• Date of registration: 08/03/2002
• Prospective Registration: No
• Primary sponsor: Swiss Group for Clinical Cancer Research
• Public title: Exemestane With or Without Bicalutamide in Treating Patients With Stage IV Prostate Cancer
• Scientific title: A Randomized Phase II Trial of Exemestane With and Without Bicalutamide as Second Line Therapy After Failure of Androgen Suppression in Advanced Prostate Cancer
• Date of first enrolment: August 2001
• Target sample size: 5
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00031889
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: Marco Bonomo, MD
• Affiliation: Ospedale Beata Vergine

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed stage IV adenocarcinoma of the prostate

- Documented disease progression based on prostate-specific antigen (PSA) progression
during first-line androgen suppression (luteinizing hormone-releasing hormone agonist
or orchiectomy)

- PSA progression is defined by the following:

- Interval of at least 1 week between reference value (time point value 1)
and the next PSA level (time point value 2)

- PSA at time point value 3 is greater than PSA at time point value 2 OR

- PSA at time point value 3 is not greater than PSA at time point value 2,
but PSA at time point value 4 is greater than PSA at time point value 2

- PSA at least 5 ng/mL

- Must continue primary androgen suppression if no prior surgical castration

- No known leptomeningeal or brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- WHO 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,500/mm^3

- Neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Other:

- No acute concurrent severe infection

- No other concurrent significant disease that would preclude study therapy

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior antibody or gene therapy

Chemotherapy:

- No prior cytostatic agents

Endocrine therapy:

- See Disease Characteristics

- No prior estramustine

- No prior antiandrogens (e.g., bicalutamide)

- No concurrent estrogen-containing medicine

Radiotherapy:

- More than 4 weeks since prior radiotherapy

- No concurrent radiotherapy to more than 1 field

Surgery:

- See Disease Characteristics

Other:

- At least 4 weeks since prior investigational drugs



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

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: Exemestane

Drug: Exemestane+bicalutamide

Secondary ID(s)

EU-20139

SAKK 09/01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors