OGX-011 and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00471432|
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : November 9, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Breast Cancer Kidney Cancer Lung Cancer Ovarian Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: custirsen sodium Drug: docetaxel Other: pharmacological study||Phase 1|
- 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.
- 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.
OUTLINE: This is an open-label, multicenter, dose-escalation study of OGX-011. Patients are sequentially assigned to 1 of 2 treatment schedules.
- Schedule A: Patients receive OGX-011 IV over 2 hours on days 1, 3, 5, 8, 15, 22, 29, and 36 of course 1 and once weekly in weeks 1-6 of all subsequent courses. Patients also receive docetaxel IV over 1 hour once weekly in weeks 1-5. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Schedule B: Patients receive OGX-011 IV over 2 hours on days -7, -5, -3, 1, 8, and 15 of course 1 and days 1, 8, and 15 of all subsequent courses. Patients also receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks (course 1 is 4 weeks in duration) for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of OGX-011 (in each schedule) until the recommended phase II dose (RPTD) is determined. The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients undergo serum collection periodically for pharmacokinetic and pharmacodynamic analysis.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel|
|Study Start Date :||March 2003|
|Actual Study Completion Date :||December 2009|
- Dose-limiting toxicity
- Recommended phase II dose of OGX-011
- Pharmacokinetic profile
- Serum clusterin levels and clusterin expression in peripheral blood mononuclear cells and accessible tumors
- Objective response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471432
|Study Chair:||Kim N. Chi, MD||British Columbia Cancer Agency|