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

Alternate Title

Cilengitide in Treating Patients With Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI CCUM-2004-045 6735, NCI-6735, NCT00121238

Special Category: NCI Web site featured trial

Objectives

Primary

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

Secondary

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

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/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

• 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

Expected Enrollment

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

Outcomes

Prostate-specific antigen (PSA) response

Mean change in PSA slope
Percent of PSA slope decrease after completion of study treatment
Efficacy
Toxicity
Survival time
Time to progression
Duration of response

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.

Trial Contact Information

Trial Lead Organizations

University of Michigan Comprehensive Cancer Center

Maha Hadi Hussain, MD, Protocol chair		Ph: 734-936-8906; 800-865-1125

Related Information

Featured trial article

Registry Information
Official Title		Phase II Evaluation of EMD121974 (NSC 707544, Cilengitide) in Patients With Non-Metastatic Androgen-Independent Prostate Cancer
Trial Start Date		2005-01-18
Trial Completion Date		2008-02-19
Registered in ClinicalTrials.gov		NCT00121238
Date Submitted to PDQ		2005-06-22
Information Last Verified		2008-08-15
NCI Grant/Contract Number		CA46592