NCT00471432CompletedPhase 1
A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- NCIC Clinical Trials Group
- Enrollment
- 40
- Primary Endpoint
- Recommended phase II dose of OGX-011
Study Overview
Brief Summary
RATIONALE: OGX-011 may kill tumor cells by blocking some of the proteins that may cause tumor cells to grow. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving OGX-011 together with docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of OGX-011 when given together with docetaxel in treating patients with metastatic or locally recurrent solid tumors.
Detailed Description
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and recommended phase II dose of OGX-011 when administered with docetaxel in patients with metastatic or locally recurrent solid tumors.
Secondary
- Determine the pharmacokinetic profile of this regimen in these patients.
- Assess the effect of OGX-011 on serum clusterin levels and clusterin expression in peripheral blood mononuclear cells and accessible tumors.
- Assess objective response in patients treated with this regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed solid tumors that have been shown to overexpress clusterin, including but not limited to, any of the following:
- •Prostate cancer
- •Renal cell carcinoma
- •Non-small cell lung cancer
- •Bladder cancer
- •Breast cancer
- •Ovarian cancer
- •Metastatic or locally recurrent disease
- •Refractory to standard curative therapy or no standard curative therapy exists
- •Patients with prostate cancer must be hormone refractory (i.e., have documented evidence of progression while receiving androgen ablative therapy)
- •Measurable or nonmeasurable disease
- •Measurable disease defined as measurable lesion ≥ 20 mm by x-ray, physical exam, or nonspiral CT scan or ≥ 10 mm by spiral CT scan
- •No documented CNS metastases
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Absolute granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin normal
- •Creatinine ≤ 2 times upper limit of normal (ULN)
- •AST and ALT ≤ 1.5 times ULN
- •PT/INR and PTT normal
- •No uncontrolled pain
- •No known bleeding disorder
- •No history of serious allergic reaction to taxane (paclitaxel or docetaxel)
- •No preexisting peripheral neuropathy ≥ grade 2
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other serious illness or medical conditions that would preclude study compliance, including any of the following:
- •Active uncontrolled infection
- •Significant cardiac dysfunction
- •No significant neurological disorder that would preclude giving informed consent
- •PRIOR CONCURRENT THERAPY:
- •No prior strontium chloride Sr 89
- •No more than 2 prior chemotherapy regimens, including adjuvant or neoadjuvant chemotherapy (for patients assigned to schedule B [docetaxel once every 3 weeks])
- •More than 4 weeks since prior chemotherapy and recovered
- •At least 4 weeks since prior antiandrogens
- •More than 4 weeks since prior external-beam radiotherapy, except low-dose nonmyelosuppressive radiotherapy
- •No prior radiotherapy to ≥ 30% of marrow-bearing areas (for patients assigned to schedule B [docetaxel once every 3 weeks])
- •At least 28 days since prior new anticancer therapy
- •At least 28 days since prior and no other concurrent investigational agents
- •No concurrent radiotherapy, except low-dose nonmyelosuppressive radiotherapy
- •No other concurrent cytotoxic therapy
- •Concurrent luteinizing hormone-releasing hormone agonist allowed (if already initiated in patients with prostate cancer)
- •No concurrent anticoagulant therapy (i.e., heparin, warfarin)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Recommended phase II dose of OGX-011
Dose-limiting toxicity
Secondary Outcomes
- Pharmacokinetic profile
- Objective response
- Serum clusterin levels and clusterin expression in peripheral blood mononuclear cells and accessible tumors
Investigators
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