A phase III randomized, open-label study of CG1940 and CG8711 versus docetaxel and prednisone in patients with metastatic hormone-refractory prostate cancer who are chemotherapy-naive

• Register: EUCTR
• Last refreshed on: 7 January 2013
• Main ID: EUCTR2005-002738-36-IT
• Date of registration: 05/06/2006
• Prospective Registration: Yes
• Primary sponsor: CELL GENESYS, LTD.
• Public title: A phase III randomized, open-label study of CG1940 and CG8711 versus docetaxel and prednisone in patients with metastatic hormone-refractory prostate cancer who are chemotherapy-naive
• Scientific title: A phase III randomized, open-label study of CG1940 and CG8711 versus docetaxel and prednisone in patients with metastatic hormone-refractory prostate cancer who are chemotherapy-naive
• Date of first enrolment: 14/03/2007
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002738-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Germany, Italy, Netherlands, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
*Males greater than 18 years of age *Confirmed diagnosis of or clincial history consistent with adenocarcinoma of the prostate *Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after disontinuation of anti-androgen therapy) as determined by one of the following: -progressive measurable disease on CTscan or MRI as assessed using RECIST guidelines. -progressive non-measurable disease as defined by the appearance of one or more new lesions on bone scan -PSA progression, as defined by two consecutive rising PSA values obtained at least 2 weeks apart, and both obtained at least 4 weeks after the discontinuation of any other anti-androgen therapy. The second PSA value must be >=5.0 ng/mL. *Detectable metastses by bone scan, CT scan or MRI *Testosterone < 50 ng/dL (1.73 nmol/L). Must have had orchiectomy or is currently receiving an LHRH agonist/antagonist *WBC >=3,000 cells/mm3, ANC >1,500 cells/mm£, hemoglobin >=9 g/dL (5.6 mmol/L), and platelets >= 100,000 cells mm3 *serum creatinine <2.0 mg/dL (177 micromol/L) *Total direct bilirubin <= the upper limit of normal *AST or ALT <= 1.5 times the upper limit of normal concomitant with alkaline phosphatase <= 2.5 times the upper limit of normal *CD4+ lymphocytes >200 cells/mm3 *ECOG performance status 0-2 *Life expectancy of at least 6 months *If sexually active, willing to use barrier contraception while on study drug treatment *the ability to understand and the willingness to sign a written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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:
*transitional cell, neuroendocrine, or squamous cell prostate cancer *patients taking any Level 3 pain medication at any dose with any frequency are excluded from the study. Patients taking Level 2 pain medication who are experiencing cancer related pain are not elegible for the study. *Clinical evidence of brain metastases or history of brain metastases *third space fluid accumulation, such as ascites or symptomatic pleural effusion *clinically significant active infection or uncontrolled medical condition considered high-risk for docetaxel, corticosteroids or investigational new drug tretement *prior gene therapy *prior chemotherapy or cancer vaccine for prostate cancer. Chemotherapy is defined as taxanes, mitoxantrone, estrmustine, etoposide, vinca alkaloids, cyclophosphamide and anthracyclines *radiation therapy within 4 weeks of randomization. Prior radiation must have been to less than 30% of the bone marrow and patient has recovered from all side effects. Prior use of samarium is acceptable; patients cannot have received strontium *surgery within 4 weeks of randomization. Must have recovered from all side effects. *flutamide (Eulexin) within 4 weeks of randomization *finesteride (Proscar), bicalutamide (Casodex), nilutamide (Nilandrone), within 6 weeks of randomization. *biologic therapy within 4 weeks of randomization *systemic corticostoid use within 4 weeks of randomization *history of mycardial infarction or cerebrovascular accident (CVA) within 6 months of randomization *Thrombotic event requiring anti-coagulation therapy within 4 weeks of randomization *history of myocardial infarction or cerebrovascular accident (CVA) within 6 months of randomization *thrombotic event requiring anti-coagulation therapy within 4 weeks of randomization *history of autoimmune disease such as systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerolonephritis, or vasculitis that was previously treated with cytotoxic agents or systemic steroids *history of another malignancy, except for the following: adequtely treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequtely treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years *known hypersensitivity to GM-CSF or to any other components of CG1940 and CG8711, which include fetal bovine serum (FBS), DMSO and pentastarch and may include small amounts of dextran sulfate, procine trypsin and DNase *known hypersensitivity to prednisone *known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80 *previously randomized in this study, but never received any study drug


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

metastatic hormone-refractory prostate cance
MedDRA version: 14.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Trade Name: DELTACORTENE*10CPR 5MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration number: 5-

Trade Name: TAXOTERE*INFUS FL 20MG/0,5ML+F
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
CAS Number: 114977-28-5
Concentration unit: mg milligram(s)
Concentration number: 20-

Product Name: CG1940 e CG8711
Product Code: NA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IMMUNOSTIMULANTS
Current Sponsor code: CG1940/CG8711

Primary Outcome(s)

Main Objective: The primary objective of this study is to compare the duration of survival between the two treatment arms

Primary end point(s): Duration of survival

Secondary Objective: The secondary objectives are the comparison between treatement arms of: The proportion of patients who have experienced a Bone Related Event (BRE), including spinal cord compression, surgery to bone, local radiation therapy to bone, or skeletal fracture The proportion of patients who have experienced progression of bone matastases on skeletal survey Time to onset of bone pain

Secondary ID(s)

2005-002738-36-GB

G-0029