A Phase 3 Randomized, Open-Label Study of Docetaxel in Combination with CG1940 and CG8711 versus Docetaxel and Prednisone in Taxane-Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer With Pain - G-0034

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2005-003275-20-SE
• Date of registration: 21/11/2005
• Prospective Registration: Yes
• Primary sponsor: Cell Genesys Inc.
• Public title: A Phase 3 Randomized, Open-Label Study of Docetaxel in Combination with CG1940 and CG8711 versus Docetaxel and Prednisone in Taxane-Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer With Pain - G-0034
• Scientific title: A Phase 3 Randomized, Open-Label Study of Docetaxel in Combination with CG1940 and CG8711 versus Docetaxel and Prednisone in Taxane-Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer With Pain - G-0034
• Date of first enrolment: 05/04/2006
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003275-20
• 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 Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
2 Males greater than 18 years of age
3 Patients taking any Level 3 (Opioid)pain medication at any dose with any frequency. Patients taking Level 2 (Moderate) pain medication for cancer related pain, confirmed by investigator assessment. In order to assess the source of pain and the pain medication level, the investigator should review the patient’s completed assessment(s) of pain, perform a complete medical history, including current medications and physical examination, and review results from bone and CT scans.
4 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 un-modified 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 discontinuation of any other anti-androgen therapy. The second PSA value must be = 5.0 ng/mL.
5 Detectable metastases by bone scan, CT scan or MRI.
6 Testosterone < 50 ng/dL (1.73 nmol/L). Must have had orchiectomy or is currently receiving an LHRH agonist/antagonist
7 WBC = 3,000 cells/mm3, ANC > 1,500 cells/mm3, hemoglobin = 9 g/dL (5.6 mmol/L), and platelets = 100,000 cells/mm3
8 Serum creatinine < 2.0 mg/dL (177 µmol/L)
9 Total or direct bilirubin = the upper limit of normal
10 AST or ALT = 1.5 times the upper limit of normal concomitant with alkaline phosphatase = 2.5 times the upper limit of normal.
11 CD4+ lymphocytes > 200 cells/mm3
12 ECOG performance status = 2 (performance status of 3 is allowed if due to bone pain)
13 Life expectancy of at least 6 months
14 If sexually active, willing to use barrier contraception during study drug treatment
15 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 Clinical evidence of brain metastases or history of brain metastases
3 Third space fluid accumulation, such as ascites or symptomatic pleural effusion
4 Clinically significant active infection or uncontrolled medical condition considered high-risk for docetaxel, corticosteroids or investigational new drug treatment
5 Prior gene therapy or cancer vaccine for prostate cancer
6 More than one prior systemic chemotherapy regimen, or any taxane chemotherapy. Patients must have completed chemotherapy at least 4 weeks prior to randomization and have recovered from all side effects.
7 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
8 Surgery within 4 weeks of randomization. Must have recovered from all side effects.
9 Flutamide (Eulexin) within 4 weeks of randomization.
10 Finasteride (Proscar), bicalutamide (Casodex), nilutamide (Nilandrone), within 6 weeks of randomization.
11 Biologic therapy within 4 weeks of randomization
12 Systemic corticosteroid use within 4 weeks of randomization
13 History of myocardial infarction or cerebrovascular accident (CVA) within 6 months of randomization
14 Thrombotic event requiring anti-coagulation therapy within 4 weeks of randomization
15 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
16 History of another malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission or any other cancer that has been in complete remission for at least 5 years
17 Known hypersensitivity to GM-CSF or to any of the 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
18 Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
19 Known hypersensitivity to prednisone
20 Previously randomized in this study or CGI protocol G-0029, 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/ml

Trade 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 to compare between treatment arms:
Time to radiologic disease progression
Time to pain progression

Secondary ID(s)

2005-003275-20-GB

G-0034