SB-715992 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Docetaxel or Paclitaxel

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

In brief

Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well SB-715992 works in treating patients with metastatic prostate cancer that did not respond to docetaxel or paclitaxel

Key facts

Study ID

NCT00096499

Run by

National Cancer Institute (NCI)

People needed

40

Starts

2005-04-01

Last updated by the study team

2013-01-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate
• Metastatic disease (N1 and/or M1)
• Unresponsive or refractory to androgen-deprivation therapy
• Must have received one, and only one, prior taxane-containing (docetaxel or paclitaxel) chemotherapy regimen for metastatic disease that was discontinued due to disease progression, intolerance, or patient request
• Evidence of disease progression as defined by ≥ 1 of the following:
• Progression of measurable disease
• Progression of evaluable disease
• Rising prostate-specific antigen (PSA)
• At least 2 consecutive rises in PSA levels, each taken ≥ 7 days apart
• PSA ≥ 5 ng/mL
• Must have pre-study PSA > 5 ng/mL
• Measurable or evaluable disease
• Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
• Soft tissue disease that has been irradiated ≥ 2 months prior to study entry is considered measurable disease provided the lesion progressed after radiation
• Surgical or medical castration required
• If luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or LHRH antagonists (abarelix) were used, then must continue use during study therapy
• No prior or concurrent brain metastases (treated or untreated)
• If clinical suspicion of brain metastases, must meet the following criteria:
• Brain CT scan or MRI negative for metastatic disease within the past 56 days
• No new symptoms since radiographic evaluation
• Performance status - Zubrod 0-2
• Absolute granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• Bilirubin normal

Where it is running

• Southwest Oncology Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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