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A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

Thank you

Trial Information

A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer


I. Determine the prostate-specific antigen response to SB-715992 in patients with
hormone-refractory, androgen-independent metastatic prostate cancer that failed prior
taxane-based chemotherapy.


I. Determine the median overall survival and median progression-free survival of patients
treated with this drug.

II. Determine the objective response rate (confirmed and unconfirmed, complete and partial
response) in patients with measurable disease treated with this drug.

III. Determine the qualitative and quantitative toxic effects of this drug in these

IV. Determine, preliminarily, the pharmacokinetics and mechanism of activity of this drug in
these patients.

OUTLINE: This is a multicenter study.

Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 1.3-2.7

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Probability of PSA response

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Tomasz Beer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Southwest Oncology Group San Antonio, Texas  78245