Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Michigan Comprehensive Cancer Center

Maha Hadi A. Hussain

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00121238
Information obtained from ClinicalTrials.gov on December 14, 2011

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