Recurrent Prostate CancerPhase 2NCT00121238

Cilengitide in Treating Patients With Prostate Cancer

A Phase 2 study testing cilengitide in people with Recurrent Prostate Cancer and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer
What is being tested?: cilengitide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Jan 2005to Nov 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 21Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan University Hospital
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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

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

Read the detailed description

PRIMARY OBJECTIVES:

To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer.

SECONDARY OBJECTIVES:

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:

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.

Conditions: Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
Being tested: cilengitide
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cilengitideDrug
Also called EMD 121974
Given IV

Study groups in NCT00121238
Study group	Role	What they receive
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. Receives: Drug: cilengitide

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 5 years

Secondary outcomes (4)

Median PSA Slope Difference
Median PSA slope difference was calculated between baseline and 6 months.
Measured: Baseline to 6 months
The Number of Participants With at Least One Incident of Toxicity
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients (16 patients were enrolled however one progressed prior to treatment) including the two ineligible patients.
Measured: Up to 5 years
Median Survival Time
6 of 13 patients were alive at five years. The Median survival time was calculated for all patients.
Measured: Up to 5 years
Mean Time to Progression of Prostate Cancer
Kaplan-Meier estimates of time to progression will be reported.
Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Nov 2015

First posted21 Jul 2005 (estimated)
Study startJan 2005
Primary completionNov 2010
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Recurrent Prostate CancerStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00121238
Sponsor's protocol ID: NCI-2012-03066
Other IDs: 2004-045, N01CM62206, CDR0000438708
Status last verified: Feb 2013
First submitted: 19 Jul 2005
Last updated: 28 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 21049281

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Evaluation of EMD 121974 (NSC 707544, Cilengitide) in Patients With Non-Metastatic Androgen Independent Prostate Cancer
ClinicalTrials.gov ID: NCT00121238
Acronym / sponsor ID: NCI-2012-03066
Conditions: Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: Jan 2005
Primary completion: Nov 2010 (actual)
Study completion: Nov 2015 (actual)
First posted: 21 Jul 2005 (estimated)
Results: Posted 28 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

PRIMARY OBJECTIVES:

To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer.

SECONDARY OBJECTIVES:

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:

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.

OUTLINE: This is an open-label, multicenter study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental treatment: cilengitide	Experimental	Drug: cilengitidePatients 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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

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
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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cilengitideAlso: EMD 121974Given IV	Drug	Experimental treatment: cilengitide

Primary outcome

The Number of Patients With a PSA Decline of ≥50%
Time frame: Up to 5 years
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.

4 secondary outcomes

Median PSA Slope Difference
Time frame: Baseline to 6 months
The Number of Participants With at Least One Incident of Toxicity
Time frame: Up to 5 years
Median Survival Time
Time frame: Up to 5 years
Mean Time to Progression of Prostate Cancer
Time frame: Up to 5 years

Results and safety

Results posted to the registry on 28 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drug Treatment (Cilengitide)	16	13

Primary outcome: The Number of Patients With a PSA Decline of ≥50%

Time frame: Up to 5 years. Number. Unit: participants

Measure	Drug Treatment (Cilengitide) n = 13
Value	0

Population analysed: Per protocol: of the 16 patients registered for this arm, 13 were analyzed. 1 patient lost eligibility due to disease progression, 2 others were censored from efficacy analysis because it was determined they were ineligible based on PSA requirements.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: During treatment with study drug for 1 year if toxicity did not halt treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drug Treatment (Cilengitide)	2 of 15 (13.3%)	15 of 15 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21049281Alva 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maha Hussain principal investigator

University of Michigan University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cilengitide in people with Recurrent Prostate Cancer and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Patients With a PSA Decline of ≥50% (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00121238, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.