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

NCT00096499 | Completed Phase 2

• 4 other identifiers: NCI-2012-02630SWOG-S0418U10CA032102CDR0000393206
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Probability of PSA response

  Up to 3 years

Secondary Outcomes (3)

• Overall survival

  From date of registration to date of death due to any cause, assessed up to 3 years

• Progression-free survival

  From date of registration to date of first observation of progressive disease, symptomatic deterioration, or death due to any cause, assessed up to 3 years

• Probability of objective response

  Up to 3 years

Study Arms (1)

Treatment (ispinesib)

EXPERIMENTAL

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.

Drug: ispinesib; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

ispinesib DRUG

Given IV

Also known as: CK0238273, SB-715992

Treatment (ispinesib)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (ispinesib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (ispinesib)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ispinesib; CK0238273

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tomasz Beer

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 10, 2004
• Study Start: April 1, 2005
• Primary Completion: January 1, 2007
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

US (1)