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A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Satraplatin plus radiation therapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Biochemical Failure, Radical Prostatectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Over or equal to 18 years of age.
ECOG performance status less than or equal to 1
Adequate organ function.
History of radical prostatectomy with histopathologic documentation of adenocarcinoma of the prostate.
PSA over or equal to 0.2 ng/ml or less than or equal to 0.4 ng/ml. This includes patients whose PSA never becomes detectable. PSA progression must be measured by two consecutive samples, each separated by over or equal to 7 days. The PSA values of the two consecutive sample values must be greater than the previous (baseline) value, not greater than each other.

Exclusion Criteria:

Known sites of measurable prostate cancer or bone scan positive for metastatic prostate cancer. (patients with a positive Prostascint scan will not be excluded)
Prior therapy for prostate cancer except RP and neoadjuvant hormonal therapy. This includes chemo, hormonal (except neoadjuvant), RT, and biologic therapy.
Lack of physical integrity of the upper GI tract, malabsorption syndromes, or inability to tolerate or absorb oral medications, including Crohn's disease and ulcerative colitis.
Other concurrent immunotherapy, RT, chemotherapy,or ancillary therapy considered investigational (utilized for non-FDA approved indications and the context of a research investigation)and any chemotherapy not included in the study protocol.

Sites / Locations

University of California San Francisco
UT Southwestern Medical Center at Dallas
The University of Texas Health Science Center at San Antonio
Medical College of Wisconsin

Outcomes

Primary Outcome Measures

Determine maximum tolerated dose and dose limiting toxicity for the combination of Satraplatin and radiation therapy.

Secondary Outcome Measures

PSA Response, Time to PSA Response, Duration of PSA response, Secondary Biochemical Recurrence Free Survival, Time to Biochemical Recurrence, Effect of Satraplatin on Serum Testosterone Levels, Safety and Tolerability.

Full Information

NCT ID

NCT00480623

First Posted

May 29, 2007

Last Updated

March 21, 2012

Sponsor

Agennix

1. Study Identification

Unique Protocol Identification Number

NCT00480623

Brief Title

A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence

Official Title

A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence Following Radical Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decided to discontinue study drug development

Study Start Date

May 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Agennix

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is designed to measure the impact of Satraplatin plus radiation therapy to the bed of the prostate in patients who have developed biochemical failure of their prostate cancer. The main objective of this study is to determine the maximum tolerated dose and dose limiting toxicity for the combination of satraplatin and radiation therapy and to determine the recommended dose for subsequent Phase II trials.

Detailed Description

****Please Note: Dr.Howard Sandler's site will be open to accrual shortly, Dr. Sarantopoulos's site in San Antonio is open and recruiting patients.**** There were approximately 232,000 cases of prostate cancer diagnosed in the US in 2005. Most patients present with localized disease and undergo curative therapy, either radical prostatectomy (RP) or radiation therapy (RT). Although most men are cured after this therapy, approximately 30,000-50,000 annually in the US will develop recurrence after RP. For most of these patients, recurrence will be defined by biochemical recurrence (BCR), a rise in PSA with no other documented evidence of recurrence. Patients with BCR typically receive radiation therapy to the prostate bed. However, about 50% of these patients will develop distant recurrence outside of the pelvis and require systemic therapy. Satraplatin is a third generation orally administered platinum compound. Early clinical studies demonstrated activity in tumors of the ovary and lung in addition to prostate cancer. Satraplatin has shown activity in prostate cancer in Phase II studies and has been evaluated in a pivotal Phase III study (The SPARC trial)as a single agent as second line therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate Cancer, Biochemical Failure, Radical Prostatectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Satraplatin plus radiation therapy

Primary Outcome Measure Information:

Title

Determine maximum tolerated dose and dose limiting toxicity for the combination of Satraplatin and radiation therapy.

Time Frame

Serum chemistry and CBC will be evaluated weekly. PSA level will be evaluated on Day on of week 5.

Secondary Outcome Measure Information:

Title

Time Frame

PSA level will be evaluated on Day on of week 5. There will be an end of treatment visit within 30 days of the last RT-Satraplatin treatment. PSA will be drawn every 3 m for 2 years, then every 6 m until evidence of either PSA or clinical progression.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Over or equal to 18 years of age. ECOG performance status less than or equal to 1 Adequate organ function. History of radical prostatectomy with histopathologic documentation of adenocarcinoma of the prostate. PSA over or equal to 0.2 ng/ml or less than or equal to 0.4 ng/ml. This includes patients whose PSA never becomes detectable. PSA progression must be measured by two consecutive samples, each separated by over or equal to 7 days. The PSA values of the two consecutive sample values must be greater than the previous (baseline) value, not greater than each other. Exclusion Criteria: Known sites of measurable prostate cancer or bone scan positive for metastatic prostate cancer. (patients with a positive Prostascint scan will not be excluded) Prior therapy for prostate cancer except RP and neoadjuvant hormonal therapy. This includes chemo, hormonal (except neoadjuvant), RT, and biologic therapy. Lack of physical integrity of the upper GI tract, malabsorption syndromes, or inability to tolerate or absorb oral medications, including Crohn's disease and ulcerative colitis. Other concurrent immunotherapy, RT, chemotherapy,or ancillary therapy considered investigational (utilized for non-FDA approved indications and the context of a research investigation)and any chemotherapy not included in the study protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Howard Sandler, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

UT Southwestern Medical Center at Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

The University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78230

Country

United States

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence

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