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Title: A Pilot Study Evaluating the Safety and Feasibility of Custirsen (OGX-011) in Combination With Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Title: A Pilot Study Evaluating the Safety and Feasibility of Custirsen (OGX-011) in Combination With Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer

This study was initiated as a multicenter, open-label, randomized study, with a planned
enrollment of 40 subjects. Although two treatment arms were included in this study, no
comparison between the arms was intended.

Subjects with metastatic HRPC who failed first-line docetaxel therapy and required
second-line therapy were randomly assigned to treatment with OGX-011 in combination with
docetaxel/prednisone (OGX-011/docetaxel/prednisone) or OGX-011 in combination with
mitoxantrone/prednisone (OGX-011/mitoxantrone/ prednisone). The study was randomized to
assure that subjects were enrolled in each of the two treatment arms in an unbiased manner.

Based on preliminary safety data from the first 44 subjects who were randomized to receive
either docetaxel or mitoxantrone, the protocol was amended to enroll approximately 20
additional subjects who would be assigned to the docetaxel/prednisone treatment arm to
further investigate safety of the combination.

Inclusion Criteria:

1. Age ≥ 18 years

2. Histologic diagnosis of adenocarcinoma of the prostate.

3. Metastatic disease on chest X-ray, bone scan, or computed tomography (CT) scan.

4. 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.

5. 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

- SGOT (AST) ≤ 1.5 x ULN

- Castrate serum testosterone level (< 50 ng/mL-or-< 1.7 mmol/L).

6. If not treated with bilateral orchiectomy, patients must be willing to continue
luteinizing hormone releasing hormone analogues throughout the study.

7. Adequate bone marrow function defined as absolute neutrophil count (ANC) ≥ 1.5 x 10^9
cells/L and platelet count ≥ 100 x 10^9/L.

8. Karnofsky score ≥ 60

9. Received no other chemotherapy, radioisotope therapy, strontium 89, or samarium 153.
(Prior radiotherapy and steroids following first line docetaxel therapy are allowed.)

10. Received no more than one prior biological response modifier therapy following first
line docetaxel therapy.

11. At least 21 days since completing the last dose of docetaxel, biological response
modifier, and/or radiotherapy. (Exception for radiotherapy: at least 7 days since
completing a single fraction of ≤ 800 cGy to a restricted field.)

12. Has recovered from all therapy related toxicity to ≤ grade 2, (except alopecia and

13. Willing and able to give informed consent and follow protocol requirements.

Exclusion Criteria:

1. Life expectancy less than 12 weeks.

2. Patient is beyond 6 months following the last dose of docetaxel.

3. Patient could not tolerate a dose of docetaxel of at least 45 mg/m² at the end of
first line therapy due to toxicity.

4. History of or current documented brain metastasis or carcinomatous meningitis,
treated or untreated. (Brain imaging in asymptomatic patients is not required.)

5. Current symptomatic cord compression requiring surgery or radiation therapy. (Once
treated, patients are eligible for the study.)

6. Active second malignancy (except non melanomatous skin or superficial bladder

7. Prior radiotherapy to > 25% of the bone marrow.

8. 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.

9. History of or active congestive heart failure.

10. Known allergy or hypersensitivity to docetaxel or polysorbate 80 (diluent).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.

Outcome Description:

Safety and tolerability were based on Adverse Events (AE) and Serious Adverse Events (SAE) graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). The CTCAE has 5 grades with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1=Mild AE; Grade 2=Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE; and Grade 5=Death related to AE.

Outcome Time Frame:

Subjects were followed for safety from enrollment for up to 8 months (9 three-week cycles plus 30 days after end of treatment)

Safety Issue:


Principal Investigator

Fred Saad, MD, FRCS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Université de Montréal


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

October 2010

Related Keywords:

  • Prostate Cancer
  • Metastatic hormone refractory prostate cancer (HRPC)
  • Prostatic Neoplasms