Status:
COMPLETED
SB-715992 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Docetaxel or Paclitaxel
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 treatin...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the prostate-specific antigen response to SB-715992 in patients with hormone-refractory, androgen-independent metastatic prostate cancer that failed prior taxane-base...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance ≥ 40 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Fertile patients must use effective contraception
- No peripheral neuropathy ≥ grade 2
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study participation
- No other uncontrolled illness
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer in complete remission
- No colony-stimulating factors during the first course of study therapy
- No concurrent anticancer biologic therapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy and recovered
- See Disease Characteristics
- At least 4 weeks since prior flutamide or ketoconazole
- At least 6 weeks since prior bicalutamide or nilutamide
- No concurrent anticancer hormonal therapy except LHRH agonist or antagonist for patients who have not undergone orchiectomy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- Prior samarium Sm 153 lexidronam pentasodium allowed
- No prior strontium chloride Sr 89
- No prior radiotherapy to ≥ 30% of bone marrow
- No concurrent anticancer radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior surgery and recovered
- At least 2 weeks since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:
- Clarithromycin
- Erythromycin
- Troleandomycin
- Rifampin
- Rifabutin
- Rifapentine
- Itraconazole
- Ketoconazole
- Fluconazole (dose \> 200 mg/day)
- Voriconazole
- Nefazodone
- Fluvoxamine
- Verapamil
- Diltiazem
- Grapefruit juice
- Bitter orange
- Phenytoin
- Carbamazepine
- Phenobarbital
- Oxcarbazepine
- Hypericum perforatum (St. John's wort)
- Modafinil
- At least 6 months since prior and no concurrent amiodarone
- No other investigational drugs for 4 weeks before, during, and for 2 weeks after study therapy
- No other concurrent anticancer cytotoxic therapy
- No other concurrent anticancer therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Concurrent enrollment on SWOG-9205 (central prostate cancer serum repository protocol) allowed
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00096499
Start Date
April 1 2005
Last Update
January 25 2013
Active Locations (1)
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1
Southwest Oncology Group
San Antonio, Texas, United States, 78245