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


Phase 2
18 Years
N/A
Not Enrolling
Male
Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA response, defined as a drop in PSA of at least 50% from the final pre-treatment value

Outcome Description:

Efficacy will be reported as rates plus confidence intervals.

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Maha Hussain

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan University Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03066

NCT ID:

NCT00121238

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Recurrent Prostate Cancer
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer
  • Prostatic Neoplasms

Name

Location

University of Michigan University Hospital Ann Arbor, Michigan  48109