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Cilengitide in Treating Patients With Metastatic Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: February 7, 2005   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: University of Michigan Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00103337
  Purpose

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

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


Condition Intervention Phase
Prostate Cancer
Drug: cilengitide
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Evaluation of EMD121974 (NSC 707544, Cilengitide) in Asymptomatic Patients With Metastatic Androgen Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical progression as measured by bone scan or CT scan at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response as measured by RECIST criteria [ Designated as safety issue: No ]
  • Prostate-specific antigen (PSA) response [ Designated as safety issue: No ]
  • Time to clinical and PSA response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Time to progression [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: April 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of 2 different dose levels of cilengitide, in terms of 6-month clinical progression, in patients with asymptomatic, metastatic, androgen-independent prostate cancer.

Secondary

  • Determine the safety of 2 different dose levels of this drug in these patients.
  • Determine the objective response rate in patients with bidimensionally measurable disease treated with 2 different dose levels of this drug.
  • Determine the rate of ≥ 50% decline in prostate-specific antigen level in patients treated with 2 different dose levels of this drug.

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.

Patients receive cilengitide IV over 1 hour twice a week for 6 weeks. 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.

PROJECTED ACCRUAL: A total of 106 patients (53 per dose level) will be accrued for this study within 2 years.

  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

    • Metastatic disease

      • Progressive disease despite androgen-deprivation therapy and antiandrogen withdrawal, defined by at least one of the following criteria:

        • Rising prostate-specific antigen (PSA) defined by 1 of the following criteria:

          • 3 consecutive rising PSA levels, with an interval of ≥ 2 weeks between each reading AND most recent reading ≥ 5 ng/mL within the past 2 weeks
          • PSA ≥ 20 ng/mL within the past year AND confirmed within the past 2 weeks
          • 50% rise in PSA within the past 6 months AND most recent reading ≥ 5 ng/mL within the past 2 weeks
        • Progression of bidimensionally measurable soft tissue (nodal metastasis) by CT scan or MRI of the abdomen and pelvis within the past 4 weeks
        • Progression of bone disease (evaluable disease)

          • New bone lesions by bone scan within the past 6 weeks
  • PSA ≥ 5 ng/mL
  • Testosterone < 50 ng/dL

    • Primary androgen deprivation with a luteinizing hormone-releasing hormone analogue must continue during study treatment if patient has not undergone orchiectomy
  • No prostate cancer-related pain
  • No visceral lung or liver metastasis
  • No known brain metastases

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
  • WBC ≥ 3,000/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

  • 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 active malignancy within the past 2 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for metastatic disease

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • Prior radiotherapy allowed provided bone marrow function is adequate

Surgery

  • See Disease Characteristics
  • At least 4 weeks since prior major surgery

Other

  • No more than 1 prior noncytotoxic therapy for metastatic disease
  • No other concurrent commercial agents or therapies for the malignancy
  • No other concurrent investigational agents
  • No concurrent herbal, alternative, or food supplements (e.g., PC-SPES, saw palmetto, Hypericum perforatum [St. John's wort])

    • A daily multivitamin is allowed
  • No initiation of bisphosphonate therapy immediately prior to or during study therapy

    • Concurrent bisphosphonates allowed provided dose is stable and was started ≥ 6 weeks ago and progressive disease has occurred
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103337

Locations
United States, California
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
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, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Maha Hadi A. Hussain, MD University of Michigan Cancer Center
  More Information

Additional Information:
Publications:
Bradley DA, Dunn R, Ryan C, et al.: EMD121974 (NSC 707544, cilengitide) in asymptomatic metastatic androgen independent prostate cancer (AIPCa) patients (pts): a randomized trial by the Prostate Cancer Clinical Trials Consortium (NCI 6372). [Abstract] J Clin Oncol 25 (Suppl 18): A-5137, 268s, 2007.
Beekman KW, Colevas AD, Cooney K, Dipaola R, Dunn RL, Gross M, Keller ET, Pienta KJ, Ryan CJ, Smith D, Hussain M. Phase II evaluations of cilengitide in asymptomatic patients with androgen-independent prostate cancer: scientific rationale and study design. Clin Genitourin Cancer. 2006 Mar;4(4):299-302.

Study ID Numbers: CDR0000409571, CCUM-2004-030, NCI-6372, UCSF-045512, UCSF-H45860-26715-01B
Study First Received: February 7, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00103337     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Recurrence
Androgens

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

ClinicalTrials.gov processed this record on September 11, 2009