E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic Hormone-Refractory Prostate Cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Classification code | 10036909 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to compare the duration of survival between the two treatment arms. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to compare between treatment arms: Time to radiologic disease progression Time to pain progression
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Details in Protocol. Sub-study to be carrid out in US and Canada only - NOT in the EU |
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E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is duration of survival |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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A total of 400 deaths in the two treatment arms at the time of the final analysis will provide at least 80% power to detect a 33% improvement in median survival in the docetaxel and vaccine arm compared to the docetaxel and prednisone arm. It is assumed that 600 patients followed for approximately 3½-years will permit observation of 400 deaths. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |