|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Michigan Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00121238 |
Purpose
RATIONALE: Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well cilengitide works in treating patients with prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: cilengitide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Evaluation of EMD121974 (NSC 707544, Cilengitide) in Patients With Non-Metastatic Androgen-Independent Prostate Cancer |
| Estimated Enrollment: | 32 |
| Study Start Date: | January 2005 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 16 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Prostate-specific antigen (PSA)-only progression despite androgen deprivation therapy and antiandrogen withdrawal, defined as 3 consecutive rising PSA levels with an interval of > 1 week between each determination AND most recent PSA ≥ 2 ng/mL* within the past 2 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent herbal or alternative therapy or food supplements (e.g., PC-SPES, saw palmetto, or Hypericum perforatum [St. John's wort])
Concurrent bisphosphonates allowed provided dose is stable and was started ≥ 6 weeks ago and patient demonstrates subsequent PSA progression
Contacts and Locations| United States, California | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, New York | |
| Memorial Sloan - Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Maha Hadi A. Hussain, MD | University of Michigan Cancer Center |
More Information
| Responsible Party: | David Paul Kelsen, Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00121238 History of Changes |
| Other Study ID Numbers: | CDR0000438708, P30CA046592, CCUM-2004-045, NCI-6735 |
| Study First Received: | July 19, 2005 |
| Last Updated: | March 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |