Status:
COMPLETED
Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC
Lead Sponsor:
Achieve Life Sciences
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 doce...
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 ar...
Eligibility Criteria
Inclusion
- 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 (\< 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.
Exclusion
- 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).
- 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).
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00327340
Start Date
July 1 2006
End Date
October 1 2010
Last Update
October 5 2012
Active Locations (10)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada
2
Cross Cancer Institute
Edmonton, Alberta, Canada
3
BC Cancer Agency
Vancouver, British Columbia, Canada
4
CancerCare Manitoba
Winnipeg, Manitoba, Canada