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Prostate CancerPhase 2NCT00327340

Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC

A Phase 2 study testing custirsen (OGX-011)/mitoxantrone and custirsen (OGX-011)/docetaxel in people with Prostate Cancer, run by Achieve Life Sciences at 10 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
custirsen (OGX-011)/mitoxantrone and custirsen (OGX-011)/docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
10 sitesCanada
Study dates
Jul 2006to Oct 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 (< 50 ng/mL-or-< 1.7 mmol/L).
  • If not treated with bilateral orchiectomy, patients must be willing to continue luteinizing hormone releasing hormone analogues throughout the study.
  • 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.
  • Karnofsky score ≥ 60
  • Received no other chemotherapy, radioisotope therapy, strontium 89, or samarium 153. (Prior radiotherapy and steroids following first line docetaxel therapy are allowed.)
  • Received no more than one prior biological response modifier therapy following first line docetaxel therapy.
  • 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.)
  • Has recovered from all therapy related toxicity to ≤ grade 2, (except alopecia and anemia.)
  • Willing and able to give informed consent and follow protocol requirements.

Who cannot join

  • Life expectancy less than 12 weeks.
  • Patient is beyond 6 months following the last dose of docetaxel.
  • Patient could not tolerate a dose of docetaxel of at least 45 mg/m² at the end of first line therapy due to toxicity.
  • History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. (Brain imaging in asymptomatic patients is not required.)
  • Current symptomatic cord compression requiring surgery or radiation therapy. (Once treated, patients are eligible for the study.)
  • Active second malignancy (except non melanomatous skin or superficial bladder cancer).
Show all 10Show fewer
  • Prior radiotherapy to > 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).

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Canada10 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta

  • Cross Cancer Institute

    Edmonton, Alberta

  • QEII Health Sciences

    Halifax, Nova Scotia

  • Juravinski Cancer Centre

    Hamilton, Ontario

  • London Regional Cancer Program

    London, Ontario

  • Jewish General Hospital

    Montreal, Quebec

  • University of Montreal

    Montreal, Quebec

  • Toronto Sunnybrook

    Toronto, Ontario

  • BC Cancer Agency

    Vancouver, British Columbia

  • CancerCare Manitoba

    Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: 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 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.

Read the detailed description

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.

Conditions
Prostate Cancer
Being tested
custirsen (OGX-011)/mitoxantrone, custirsen (OGX-011)/docetaxel
Keywords
Metastatic hormone refractory prostate cancer (HRPC)
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • custirsen (OGX-011)/mitoxantroneDrug

    Also called custirsen, OGX-011, TV-1011

    All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to-1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21-day cycle.

    Mitoxantrone was administered IV on Day 1 of each cycle at a planned dose of 12 mg/m² infused over 30 minutes.

    Patients could receive a maximum of 9 cycles of treatment.

  • custirsen (OGX-011)/docetaxelDrug

    Also called custirsen, OGX-011, TV-1011

    All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to -1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21 day cycle.

    Docetaxel was administered IV on Day 1 of each cycle at a planned dose of 75 mg/m² infused over 60 minutes.

    Patients could receive a maximum of 9 cycles of treatment.

Study groups in NCT00327340
Study groupRoleWhat they receive
OGX-011 / mitoxantrone/prednisoneExperimentalOGX-011 / mitoxantrone/prednisone: OGX-011 administered in combination with mitoxantrone and prednisone
Receives: Drug: custirsen (OGX-011)/mitoxantrone
OGX-011/docetaxel/prednisoneExperimentalOGX-011/docetaxel/prednisone: OGX-011 administered in combination with docetaxel and prednisone
Receives: Drug: custirsen (OGX-011)/docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

Secondary outcomes (3)

  1. Feasibility of Treatment With Custirsen (OGX-011) in Combination With Second-line Chemotherapy Based on Prostate Specific Antigen (PSA) Response

    PSA or prostate specific antigen is a marker for prostate cancer. A PSA response was defined as a decrease in PSA values of ≥ 50% relative to baseline on two or more consecutive measurements that were 4-6 weeks apart.

    Measured: PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit and during off-treatment follow up (up to 27 months)

  2. 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

    Time to pain progression was defined as the time (months) from the first dose of OGX-011 to the first documentation of pain or analgesic progression or initiation of palliative radiation therapy. Pain response was defined as either a decrease of at least two points on the 11-point Worst Pain Scale, without an increase in analgesic level, maintained for at least two consecutive measurements approximately three weeks apart -or- a decrease in analgesic level, without an increase in pain score, maintained for at least two consecutive measurements approximately three weeks apart.

    Measured: Enrollment until pain progression (up to 21 months)

  3. 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.

    Serum clusterin samples were collected prior to receiving OGX-011 loading dose 1, prior to study treatment on Day 1 of each cycle, and at the end of treatment. PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit, and during off-treatment follow-up. PSA response was defined in the protocol as a decrease in PSA of ≥ 50% relative to baseline on two or more consecutive measurements 4-6 weeks apart.

    Measured: Enrollment until disease progression (up to 13 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00327340
Sponsor's protocol ID
OGX-011-07
Status last verified
Oct 2012
First submitted
16 May 2006
Last updated
5 Oct 2012
Data monitoring committee
No

Publications

  • Saad F, Hotte S, North S, Eigl B, Chi K, Czaykowski P, Wood L, Pollak M, Berry S, Lattouf JB, Mukherjee SD, Gleave M, Winquist E; Canadian Uro-Oncology Group. Randomized phase II trial of Custirsen (OGX-011) in combination with docetaxel or mitoxantrone as second-line therapy in patients with metastatic castrate-resistant prostate cancer progressing after first-line docetaxel: CUOG trial P-06c. Clin Cancer Res. 2011 Sep 1;17(17):5765-73. doi: 10.1158/1078-0432.CCR-11-0859. Epub 2011 Jul 25.

    PubMed 21788353

  • Blumenstein B, Saad F, Hotte S, Chi KN, Eigl B, Gleave M, Jacobs C. Reduction in serum clusterin is a potential therapeutic biomarker in patients with castration-resistant prostate cancer treated with custirsen. Cancer Med. 2013 Aug;2(4):468-77. doi: 10.1002/cam4.93. Epub 2013 May 28.

    PubMed 24156019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing custirsen (OGX-011)/mitoxantrone and custirsen (OGX-011)/docetaxel in people with Prostate Cancer, run by Achieve Life Sciences at 10 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy. (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00327340, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.

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