Phase 2
Completed N=69
Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC
Source: ClinicalTrials.gov NCT00327340 ↗Enrolled (actual)
69
Serious AEs
26.1%
Results posted
Aug 2012
Primary outcomePrimary: Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy. — 26; 26; 13; 4 percentage of participants
Summary
This study is for patients with cancer of the prostate gland that has metastasized or spread outside the prostate to other parts of the body. Patients have already been treated with a drug called docetaxel or Taxotere® (with or without the addition of a steroid called prednisone) some time in the recent past. They either did not respond to this therapy or responded to this therapy, but now the cancer is progressing (growing larger or has spread to other areas of the body).
Custirsen (OGX-011) is an experimental drug that has been shown to increase the effectiveness of chemotherapy in several kinds of tumors, including prostate cancer.
Both docetaxel and mitoxantrone have anticancer activity in prostate and are approved by Health Canada and the Food and Drug Administration for the treatment of patients with prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy. |
26; 26; 13; 4; 26; 15 | — |
| SECONDARY Feasibility of Treatment With Custirsen (OGX-011) in Combination With Second-line Chemotherapy Based on Prostate Specific Antigen (PSA) Response |
17; 31 | — |
| SECONDARY Feasibility of Treatment With OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second Line Chemotherapy Based on Time to Pain Progression |
5.2; 7.2 | — |
| SECONDARY Relationship Between Changes in Serum Clusterin Levels and Change in Serum PSA Levels When OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone is Administered as Second Line Chemotherapy. |
22; 24; 4; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Histologic diagnosis of adenocarcinoma of the prostate.
- Metastatic disease on chest X-ray, bone scan, or computed tomography (CT) scan.
- Failed after receiving a minimum of two cycles of a docetaxel based first line therapy regimen. Failure is defined as disease progression within 6 months of discontinuing first line docetaxel therapy. Disease progression is defined as one or more of the following:
- Progressive measurable (target) disease (by Response Evaluation Criteria in Solid Tumors [RECIST] criteria): at least a 20% increase in the sum of the longest diameters of measurable lesions (organ masses or lymph nodes) over the smallest sum observed (baseline or nadir) or the appearance of one or more new lesions as assessed by CT scan or chest X-ray.
- Bone scan progression: one or more new lesions on bone scan while on or following docetaxel treatment.
- Increasing serum PSA level: rise in PSA on three consecutive measurements obtained at least one week apart. If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA will be acceptable.
- Baseline laboratory values as stated below:
- Creatinine ≤ 1.5 x upper limit of normal (ULN)
- Bilirubin ≤ 1.1 x ULN (unless elevated secondary to conditions such as Gilbert's disease)
- SGOT (AST) ≤ 1.5 x ULN
- Castrate serum testosterone level ( 25% of the bone marrow.
- Uncontrolled medical conditions such as a major active infection, myocardial infarction or stroke within 3 months, uncontrolled hypertension, and/or significant concurrent medical illness, that, in the opinion of the Investigator, would preclude protocol therapy.
- History of or active congestive heart failure.
- Known allergy or hypersensitivity to docetaxel or polysorbate 80 (diluent).
Data sourced from ClinicalTrials.gov (NCT00327340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.