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Recurrent Prostate CancerPhase 2NCT00103337

Cilengitide in Treating Patients With Metastatic Prostate Cancer

A Phase 2 study testing cilengitide and laboratory biomarker analysis in people with Recurrent Prostate Cancer and Stage IV 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 randomized phase II trial is studying how well cilengitide works in treating patients with metastatic 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
What is being tested?
cilengitide and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteUnited States
Study dates
Jan 2005to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Metastatic disease that has progressed despite androgen deprivation therapy and antiandrogen withdrawal (28 days for flutamide and 42 days for bicalutamide or nilutamide); patients must demonstrate progression based on at least one of the following criteria:
  • Rising PSA - Defined as by one of the following criteria:
  • Three consecutive rising levels, with an interval of at least 2 weeks between each determination; the last determination must have a minimum value of >= 5 ng/ml and be determined within two weeks prior to registration
  • A PSA value of >= 20 ng/ml obtained within the 12 months prior to randomization and confirmed within 2 weeks prior to registration
  • A 50% rise in PSA values within 6 months prior to registration and confirmed within 2 weeks prior to registration; the last determination must have a minimum value of >= 5 ng/ml
Show all 25Show fewer
  • Progression of bidimensionally measurable soft tissue (nodal metastasis) assessed within 28 days prior to registration by a CT scan or MRI of the abdomen and pelvis
  • Progression of bone disease (evaluable disease) (new bone lesion(s)) by bone scan within 42 days prior to registration
  • ECOG performance status of 0-2
  • Minimum PSA >= 5 ng/mL determined within 14 days of registration
  • Testosterone < 50 ng/dL; patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy
  • Patients must have no prostate cancer-related pain, and no visceral metastasis (lung and/or liver)
  • No prior chemotherapy for metastatic disease; no more than one prior non-cytotoxic therapy for metastatic disease
  • No investigational or commercial agents or therapies may be administered with the intent to treat the patient's malignancy; four weeks must have elapsed since major surgery
  • Prior radiotherapy is allowed as long as the bone marrow function is adequate
  • Life expectancy of greater than 6 months
  • WBC >= 3,000/µl
  • 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
  • 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 document that is approved by the Institutional Human Investigation Committee (HIC)

Who cannot join

  • Patients may not be receiving any other investigational agents
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • 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 tumor 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 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 EMD121974 (NSC 707544, Cilengitide) in Asymptomatic Patients With Metastatic Androgen Independent Prostate Cancer

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the efficacy, as measured by the rates of clinical progression at six-months, of two dose levels of EMD121974 in patients with asymptomatic metastatic androgen-independent prostate cancer.

SECONDARY OBJECTIVES:

  1. To evaluate the safety of the two dose levels of EMD121974 in patients with metastatic androgen-independent prostate cancer.

II. To assess the objective response rate of two dose levels of EMD121974 in patients with metastatic androgen-independent prostate cancer and bidimensionally measurable disease.

III. To assess the rate of 50% or greater decline in the level of Prostate Specific Antigen.

TERTIARY OBJECTIVES:

  1. To determine the effects of integrin αvβ3 and αvβ5 inhibition on total circulating tumor cells and endothelial cells isolated from peripheral blood and bone marrow aspirates from patients with metastatic androgen-independent prostate cancer.

II. To study the genotypic/phenotypic variances in circulating tumor cells in patients with 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 metastatic androgen-independent prostate cancer before and after integrin αvβ3 and αvβ5 inhibition.

IV. Determine the effects of integrin αvβ3 and αvβ5 inhibition on systemic bone remodeling markers in patients with metastatic androgen-independent prostate cancer.

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.

ARM I: Patients receive lower dose cilengitide IV over 1 hour twice a week for 6 weeks.

AMR II: Patients receive higher dose cilengitide IV over 1 hour twice a week for 6 weeks.

In both arms, 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.

Being tested
cilengitide, laboratory biomarker analysis
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

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00103337
Study groupRoleWhat they receive
Arm I (500 mg cilengitide)ExperimentalPatients receive lower dose cilengitide IV over 1 hour twice a week for 6 weeks.
Receives: Drug: cilengitide; Other: laboratory biomarker analysis
Arm II (2000 mg cilengitide)ExperimentalPatients receive higher dose cilengitide IV over 1 hour twice a week for 6 weeks.
Receives: Drug: cilengitide; Other: laboratory biomarker analysis

What is being measured

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

  1. Clinical progression by bone scan or CT scan

    Measured: 6 months

Secondary outcomes (5)

  1. Objective response using RECIST

    Measured: Up to 30 days post-treatment

  2. PSA response based on recommendations from the PSA Working Group

    Measured: Up to 30 days post-treatment

  3. Time to clinical response

    Measured: Up to 30 days post-treatment

  4. Time to PSA response

    Measured: Up to 30 days post-treatment

  5. Incidence of toxicity as assessed by CTCAE v3.0

    Measured: Up to 30 days post-treatment

Timeline

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

  1. First posted8 Feb 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionOct 2007

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00103337
Sponsor's protocol ID
NCI-2012-02904
Other IDs
UMCC 2004.030, N01CM62202
Status last verified
Feb 2013
First submitted
7 Feb 2005
Last updated
28 Feb 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cilengitide and laboratory biomarker analysis in people with Recurrent Prostate Cancer and Stage IV 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 25 inclusion and 6 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 Feb 2013. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Clinical progression by bone scan or CT scan (time frame: 6 months). 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 NCT00103337.

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 Feb 2013.

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