Cilengitide in Treating Patients With Prostate Cancer

NCT00121238 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2012-030662004-045N01CM62206CDR0000438708
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The Number of Patients With a PSA Decline of ≥50%

  To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer. This measure defined as a drop in PSA of at least 50% from the final pre-treatment value.

  Up to 5 years

Secondary Outcomes (4)

• Median PSA Slope Difference

  Baseline to 6 months

• The Number of Participants With at Least One Incident of Toxicity

  Up to 5 years

• Median Survival Time

  Up to 5 years

• Mean Time to Progression of Prostate Cancer

  Up to 5 years

Study Arms (1)

Experimental treatment: cilengitide

EXPERIMENTAL

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.

Drug: cilengitide

Interventions

cilengitide DRUG

Given IV

Also known as: EMD 121974

Experimental treatment: cilengitide

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Michigan University Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Alva A, Slovin S, Daignault S, Carducci M, Dipaola R, Pienta K, Agus D, Cooney K, Chen A, Smith DC, Hussain M. Phase II study of cilengitide (EMD 121974, NSC 707544) in patients with non-metastatic castration resistant prostate cancer, NCI-6735. A study by the DOD/PCF prostate cancer clinical trials consortium. Invest New Drugs. 2012 Apr;30(2):749-57. doi: 10.1007/s10637-010-9573-5. Epub 2010 Nov 4.

  PMID: 21049281 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cilengitide

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Maha Hussain, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

mahahuss@med.umich.edu

(734)936-8906

Study Officials

• Maha Hussain

  University of Michigan University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: July 19, 2005
• First Posted: July 21, 2005
• Study Start: January 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2015
• Last Updated: April 28, 2016
• Results First Posted: April 28, 2016

Record last verified: 2013-02

Locations

US (1)