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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00471432 |
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 | Intervention | 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 I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel |
Estimated Enrollment: | 30 |
Study Start Date: | March 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter, dose-escalation study of OGX-011. Patients are sequentially assigned to 1 of 2 treatment schedules.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumors that have been shown to overexpress clusterin, including but not limited to, any of the following:
Refractory to standard curative therapy or no standard curative therapy exists
Measurable or nonmeasurable disease
PATIENT CHARACTERISTICS:
No other serious illness or medical conditions that would preclude study compliance, including any of the following:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000547039, CAN-NCIC-IND154, ONCOGENEX-OGX-01-02 |
Study First Received: | May 8, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00471432 History of Changes |
Health Authority: | United States: Federal Government |
recurrent prostate cancer stage IV prostate cancer recurrent renal cell cancer stage IV renal cell cancer recurrent non-small cell lung cancer stage IV non-small cell lung cancer recurrent bladder cancer |
stage IV bladder cancer recurrent breast cancer stage IV breast cancer recurrent ovarian epithelial cancer stage IV ovarian epithelial cancer unspecified adult solid tumor, protocol specific male breast cancer |
Thoracic Neoplasms Urinary Tract Neoplasm Prostatic Diseases Genital Neoplasms, Male Gonadal Disorders Urogenital Neoplasms Breast Cancer, Male Ovarian Diseases Urologic Neoplasms Docetaxel Genital Diseases, Female Renal Cancer Urologic Diseases Respiratory Tract Diseases Kidney Neoplasms |
Lung Neoplasms Ovarian Cancer Bladder Neoplasm Kidney Diseases Breast Diseases Endocrine Gland Neoplasms Kidney Cancer Ovarian Neoplasms Cystocele Skin Diseases Urinary Bladder Diseases Genital Neoplasms, Female Urinary Bladder Neoplasms Endocrine System Diseases Breast Neoplasms |
Thoracic Neoplasms Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Urologic Neoplasms Docetaxel Genital Diseases, Female Neoplasms by Site Urologic Diseases Respiratory Tract Diseases Lung Neoplasms Kidney Neoplasms |
Therapeutic Uses Kidney Diseases Breast Diseases Endocrine Gland Neoplasms Respiratory Tract Neoplasms Ovarian Neoplasms Neoplasms by Histologic Type Skin Diseases Urinary Bladder Diseases Genital Neoplasms, Female Urinary Bladder Neoplasms Endocrine System Diseases Breast Neoplasms Genital Diseases, Male Pharmacologic Actions |