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UMCC 2004.045 Cilengitide in Treating Patients With Prostate Cancer (IRB 2004-731)
This study has been completed.

First Received on July 19, 2005.   Last Updated on March 22, 2011   History of Changes
Sponsor: University of Michigan Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00121238
  Purpose

RATIONALE: Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well cilengitide works in treating patients with prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: cilengitide
Phase II

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of EMD121974 (NSC 707544, Cilengitide) in Patients With Non-Metastatic Androgen-Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in PSA slope [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percent of PSA slope decrease after completion of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Survival time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2005
Study Completion Date: February 2011
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cilengitide
    Eligible patients will receive EMD121974 2,000 mg, IV over 1-hour, twice weekly. A cycle will consist of 4 weeks of treatment. Refer to protocol section 4.4 for duration of treatment. Study Calender in protocol (section 8) outlines baseline and ongoing evaluations.
    Other Name: EMD121974
Detailed Description:

OBJECTIVES:

Primary

  • Determine the prostate-specific antigen (PSA) response rate in patients with non-metastatic androgen-independent prostate cancer treated with cilengitide.

Secondary

  • Determine the safety of this drug in these patients.
  • Determine the change in slope of PSA in patients treated with this drug.
  • Determine the duration of response, time to progression, and survival of patients treated with this drug.

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.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 16 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed prostate cancer
  • Prostate-specific antigen (PSA)-only progression despite androgen deprivation therapy and antiandrogen withdrawal, defined as 3 consecutive rising PSA levels with an interval of > 1 week between each determination AND most recent PSA ≥ 2 ng/mL* within the past 2 weeks

    • Patients receiving luteinizing hormone-releasing hormone (LHRH) agonist therapy must continue LHRH agonist therapy during study participation NOTE: *If the third confirmatory PSA level is < the second level, the patient is considered eligible provided a fourth PSA level is > the second level
  • No evidence of local disease progression
  • No evidence of metastatic disease
  • Must be on concurrent primary androgen deprivation with an LHRH agonist, if no prior orchiectomy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Testosterone < 50 ng/dL
  • Fertile patients must use effective contraception
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No other currently active malignancy within the past 2 years except nonmelanoma skin cancer or superficial bladder cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior cilengitide

Chemotherapy

  • Not specified

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide
  • At least 6 weeks since prior bicalutamide or nilutamide
  • At least 4 weeks since any other prior therapy intended to treat the cancer except luteinizing hormone-releasing hormone (LHRH) agonists or any stable dose (i.e., on current dosing for ≥ 1 month) of megestrol acetate or corticosteroids

Radiotherapy

  • Not specified

Surgery

  • At least 4 weeks since prior major surgery

Other

  • No other concurrent investigational or commercial agents or therapies for the malignancy
  • No concurrent herbal or alternative therapy or food supplements (e.g., PC-SPES, saw palmetto, or Hypericum perforatum [St. John's wort])

    • Concurrent daily multivitamin allowed
  • Concurrent bisphosphonates allowed provided dose is stable and was started ≥ 6 weeks ago and patient demonstrates subsequent PSA progression

    • No initiation of bisphosphonate therapy immediately prior to or during study therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121238

Locations
United States, California
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, New York
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Study Chair: Maha Hadi A. Hussain, MD University of Michigan Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: David Paul Kelsen, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00121238     History of Changes
Other Study ID Numbers: CDR0000438708, P30CA046592, CCUM-2004-045, NCI-6735
Study First Received: July 19, 2005
Last Updated: March 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan Cancer Center:
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012