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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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 treating patients with metastatic prostate cancer that did not respond to docetaxel or paclitaxel

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

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