OGX-011 and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Solid Tumors (NCT00471432) | Clinical Trial Compass
CompletedPhase 1
OGX-011 and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Solid Tumors
40 participantsStarted 2003-04-04
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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 preclu…