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-Naïve

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2005-002738-36-NL
• Date of registration: 15/06/2006
• Prospective Registration: Yes
• Primary sponsor: Cell Genesys Inc
• 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-Naïve
• 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-Naïve
• Date of first enrolment: 14/03/2007
• Target sample size: 600
• Recruitment status: Authorised-recruitment may be ongoing or finished
• 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

Countries of recruitment

Germany, Italy, Netherlands, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1 Males greater than 18 years of age
2 Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
3 Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy) as determined by one of the following:
• Progressive measurable disease on CT scan 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.
4 Detectable metastases by bone scan, CT scan or MRI
5 Testosterone < 50 ng/dL (1.73 nmol/L). Must have had orchiectomy or is currently receiving an LHRH agonist/antagonist
6 WBC = 3,000 cells/mm3, ANC > 1,500 cells/mm3, hemoglobin = 9 g/dL (5.6 mmol/L), and platelets = 100,000 cells/mm3
7 Serum creatinine < 2.0 mg/dL (177 µmol/L)
8 Total or direct bilirubin = the upper limit of normal
9 AST or ALT = 1.5 times the upper limit of normal concomitant with alkaline phosphatase = 2.5 times the upper limit of normal
10 CD4+ lymphocytes > 200 cells/mm³
11 ECOG performance status 0-2
12 Life expectancy of at least 6 months
13 If sexually active, willing to use barrier contraception while on study drug treatment
14 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:
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 Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
2 Patients taking any Level 3 (opioid) pain medication at any dose with any frequency are excluded from the study. Patients taking Level 2 (moderate) pain medication who are experiencing cancer related pain are not eligible for the study.
3 Clinical evidence of brain metastases or history of brain metastases
4 Third space fluid accumulation, such as ascites or symptomatic pleural effusion
5 Clinically significant active infection or uncontrolled medical condition considered high-risk for docetaxel, corticosteroids or investigational new drug treatment
6 Prior gene therapy
7 Prior chemotherapy or cancer vaccine for prostate cancer. Chemotherapy is defined as taxanes, mitoxantrone, estramustine, etoposide, vinca alkaloids, cyclophosphamide and anthracyclines.
8 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.
9 Surgery within 4 weeks of randomization. Must have recovered from all side effects.
10 Flutamide (Eulexin) within 4 weeks of randomization
11 Finesteride (Proscar), bicalutamide (Casodex), nilutamide (Nilandrone), within 6 weeks of randomization
12 Biologic therapy within 4 weeks of randomization
13 Systemic corticosteroid use within 4 weeks of randomization
14 History of myocardial infarction or cerebrovascular accident (CVA) within 6 months of randomization
15 Thrombotic event requiring anti-coagulation therapy within 4 weeks of randomization
16 History of autoimmune disease such as systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis that was previously treated with cytotoxic agents or systemic steroids
17 History of another malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately 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
18 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, porcine trypsin and DNase
19 Known hypersensitivity to prednisone
20 Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
21 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

Metastatic Hormone-Refractory Prostate Cancer
MedDRA version: 8.0 Classification code 10036909

Intervention(s)

Product Name: CG1940/CG8711
Pharmaceutical Form: Injection*
Current Sponsor code: CG1940/CG8711
Concentration type: not less then
Concentration number: 4x10power7 cells-cells/ml

Trade Name: Taxotere
Product Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
Other descriptive name: Taxotere
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Trade Name: Decortin
Product Name: Prednisone
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

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): The primary endpoint is duration of survival.

Secondary Objective: The secondary objectives are the comparison between treatment 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 metastases on skeletal survey.
Time to onset of bone pain

Secondary ID(s)

2005-002738-36-GB

G-0029