Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Cilengitide in Treating Patients With Metastatic Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI CCUM-2004-030 NCI-6372, 6372, UCSF-045512, UCSF-H45860-26715-01B, NCT00103337

Objectives

Primary

1. 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

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

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• WBC ≥ 3,000/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

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

Outcomes

Clinical progression as measured by bone scan or CT scan at 6 months

Objective response as measured by RECIST criteria
Prostate-specific antigen (PSA) response
Time to clinical and PSA response
Toxicity
Time to progression

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.

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, et al.: Phase II evaluations of cilengitide in asymptomatic patients with androgen-independent prostate cancer: scientific rationale and study design. Clin Genitourin Cancer 4 (4): 299-302, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

University of Michigan Comprehensive Cancer Center

Maha Hadi Hussain, MD, Principal investigator		Ph: 734-936-8906; 800-865-1125

Registry Information
Official Title		Phase II Evaluation of EMD121974 (NSC 707544, Cilengitide) in Asymptomatic Patients with Metastatic Androgen Independent Prostate Cancer
Trial Start Date		2005-04-22
Registered in ClinicalTrials.gov		NCT00103337
Date Submitted to PDQ		2004-11-30
Information Last Verified		2007-05-27
NCI Grant/Contract Number		CA46592