Expired Study
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Ann Arbor, Michigan 48109


Purpose:

This phase II trial is studying how well cilengitide works in treating patients with prostate cancer. Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor


Study summary:

PRIMARY OBJECTIVES: I. To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer. SECONDARY OBJECTIVES: I. To evaluate the safety of EMD121974 in patients with non-metastatic androgen-independent prostate cancer. II. To assess the change in the slope of Prostate Specific Antigen associated with EMD121974 in patients with non-metastatic androgen-independent prostate cancer. III. To assess response duration, time to progression and survival. TERTIARY OBJECTIVES: I. To determine the effects of integrin αvβ3 and αvβ5 inhibition on total circulating tumor and endothelial cells isolated from peripheral blood and bone marrow aspirates from patients with non-metastatic androgen-independent prostate cancer. II. To study the genotypic/phenotypic variances in circulating tumor cells in patients with non-metastatic androgen-independent prostate cancer before and after EMD121974 treatment. III. To develop a genetic profile by cDNA microarray analysis of circulating tumor cells isolated from patients with non-metastatic androgen-independent prostate cancer before and after integrin αvβ3 and αvβ5 inhibition. 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.


Criteria:

Inclusion Criteria: - A histologic or cytologic diagnosis of prostate cancer - No evidence of metastatic disease, or local progression - PSA-only progression despite androgen deprivation therapy and antiandrogen withdrawal (28 days for flutamide and 42 days for bicalutamide or nilutamide); PSA progression is defined as 3 consecutive rising levels, with an interval of > 1 week between each determination; the last determination must have a minimum value of >= 2 ng/ml and be determined within two weeks prior to registration - If the third confirmatory value is less than the previous value, the patient will still be eligible if a repeat value (No. 4) is found to be greater than the second value - Patients must continue on LHRH agonists; they also may continue on any stable doses (considered stable, if on current medicine dosing for one month or longer) of megace or corticosteroids; they must be off all other therapies intended to treat the cancer for 4 weeks - ECOG performance status of 0-2 - No prior EMD 121974 therapy is allowed - No investigational or commercial agents or therapies may be administered with the intent to treat the patient's malignancy - Testosterone < 50 ng/dl; patients must continue primary androgen deprivation with an LHRH agonist, if they have not undergone orchiectomy - Four weeks must have elapsed since major surgery - Life expectancy of greater than 6 months - Patients must have normal organ and marrow function as defined below obtained within 14 days prior to registration: - ANC >= 1,500/µl - Platelet count >= 100,000/ µl - Creatinine =< 1.5 x upper limits of normal - Bilirubin within normal limits - SGOT (AST) =< 2.5 x upper limits of normal - SGPT (ALT) =< 2.5 x upper limits of normal - PSA >= 2 ng/ml - The effects of EMD 121974 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because antiangiogenic agents are known to be teratogenic, men must agree to use adequate contraception prior to study entry and for the duration of study participation - Ability to understand and the willingness to sign a written informed consent that is approved by the Institutional Human Investigation Committee Exclusion Criteria: - Patients may continue on a daily Multi-Vitamin, but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before registration - Patients on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy, that show subsequent PSA progression, may continue on this medication, however patients are not allowed to initiate bisphosphonate therapy immediately prior or during the study - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Patients with a "currently active" second malignancy, other than non-melanoma skin cancers or superficial bladder cancer, are not eligible; patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered without evidence of disease for 2 years


Study is Available At:


Original ID:

NCI-2012-03066


NCT ID:

NCT00121238


Secondary ID:

2004-045


Study Acronym:


Brief Title:

Cilengitide in Treating Patients With Prostate Cancer


Official Title:

Phase II Evaluation of EMD 121974 (NSC 707544, Cilengitide) in Patients With Non-Metastatic Androgen Independent Prostate Cancer


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

32


Enrollment Type:

Actual


Overall Contact Information

Official Name:Maha Hussain
Principal Investigator
University of Michigan University Hospital

Study Dates

Start Date:January 2005
Primary Completion Date:November 2010
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 30, 2013
First Received Date:July 19, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:PSA response, defined as a drop in PSA of at least 50% from the final pre-treatment value
Time Frame:Up to 5 years
Safety Issues:False
Description:Efficacy will be reported as rates plus confidence intervals.
Outcome Type:Secondary Outcome
Measure:Change in PSA slope
Time Frame:Baseline to 6 months
Safety Issues:False
Description:Mean change in PSA slope will be reported, along with the percentage PSA slope decreased after treatment.
Outcome Type:Secondary Outcome
Measure:Incidence of toxicities
Time Frame:Up to 5 years
Safety Issues:True
Description:The rate of toxicities, overall and by grade, will also be reported.
Outcome Type:Secondary Outcome
Measure:Survival time
Time Frame:Up to 5 years
Safety Issues:False
Description:Kaplan-Meier estimates of survival time and time to progression will be reported, along with descriptive statistics on the duration of response.
Outcome Type:Secondary Outcome
Measure:Time to progression
Time Frame:Up to 5 years
Safety Issues:False
Description:Kaplan-Meier estimates of survival time and time to progression will be reported, along with descriptive statistics on the duration of response.
Outcome Type:Secondary Outcome
Measure:Duration of response
Time Frame:Up to 5 years
Safety Issues:False
Description:Kaplan-Meier estimates of survival time and time to progression will be reported, along with descriptive statistics on the duration of response.

Study Interventions

Intervention Type:Drug
Name:cilengitide
Description:Given IV
Arm Name:Treatment (cilengitide)
Other Name:EMD 121974
Intervention Type:Other
Name:laboratory biomarker analysis
Description:Correlative studies
Arm Name:Treatment (cilengitide)

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (cilengitide)
Description: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 diseas

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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