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Sponsors and Collaborators: |
University of Michigan Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00103337 |
RATIONALE: Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well cilengitide works in treating patients with metastatic prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: cilengitide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Evaluation of EMD121974 (NSC 707544, Cilengitide) in Asymptomatic Patients With Metastatic Androgen Independent Prostate Cancer |
Estimated Enrollment: | 106 |
Study Start Date: | April 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to prior bisphosphonate use (yes vs no). Patients are randomized to 1 of 2 doses of cilengitide.
Patients receive cilengitide IV over 1 hour twice a week for 6 weeks. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After 2 courses, patients undergo response assessment. Patients achieving a complete response (CR) receive at least 3 additional courses beyond documentation of CR. Patients with partial response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients with a mixed response may continue treatment at the discretion of the investigator.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 106 patients (53 per dose level) will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed prostate cancer
Metastatic disease
Progressive disease despite androgen-deprivation therapy and antiandrogen withdrawal, defined by at least one of the following criteria:
Rising prostate-specific antigen (PSA) defined by 1 of the following criteria:
Progression of bone disease (evaluable disease)
Testosterone < 50 ng/dL
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, alternative, or food supplements (e.g., PC-SPES, saw palmetto, Hypericum perforatum [St. John's wort])
No initiation of bisphosphonate therapy immediately prior to or during study therapy
United States, California | |
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
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, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Principal Investigator: | Maha Hadi A. Hussain, MD | University of Michigan Cancer Center |
Study ID Numbers: | CDR0000409571, CCUM-2004-030, NCI-6372, UCSF-045512, UCSF-H45860-26715-01B |
Study First Received: | February 7, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00103337 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent prostate cancer stage IV prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Prostatic Neoplasms Recurrence Androgens |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |