MDACC Study Summary 2005-0871 (Archived)

Study Summary
No. 2005-0871:.......Prostate......Paul Corn......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2005-0871

Study Title:	Phase II Evaluation of EMD121974 (NSC 707544, Cilengitide) in Asymptomatic Patients with Metastatic Androgen Independent Prostate Cancer

Physician

New Patient Referral



Name:	Paul Corn	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2830 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	The patient will return to MD Anderson 2 days each week for Cilengitide infusion. A course is 6 weeks and there are no breaks between courses.

Treatment Agents:	EMD 121974	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find out which of 2 dose levels of an investigational drug, EMD 121974 (cilengitide), may help to better control metastatic prostate cancer. The safety of this treatment will also be studied.

Study Objectives / Outcomes

Primary Objective:

1. To evaluate the efficacy, as measured by the rates of clinical progression at six-months, of two dose levels of EMD121974 (Cilengitide) in patients with asymptomatic metastatic androgen-independent prostate cancer.

Secondary Objectives:

1. To evaluate the safety of the two dose levels of Cilengitide in patients with metastatic androgen-independent prostate cancer.

2. To assess the objective response rate of two dose levels of Cilengitide in patients with metastatic androgen-independent prostate cancer and bidimensionally measureable disease.

3. To assess the rate of 50% or greater decline in the level of prostate specific antigen.

Correlative Objectives:

1. To determine the effects of integrin

₃

₅

inhibition on total circulating tumor cells and endothelial cells isolated from peripheral blood and bone marrow aspirates from patients with metastatic androgen-independent prostate cancer.

2. To study the genotypic/phenotypic variances in circulating tumor cells in patients with metastatic androgen-independent prostate cancer before and after Cilengitide treatment.

3. To develop a genetic profile by cDNA microarray analysis of circulating tumor cells isolated from patients with metastatic androgen-independent prostate cancer before and after integrin

₃

and

₅

inhibition.

4. Determine the effects of integrin

₃

and

₅

inhibition on systemic bone remodeling markers in patients with metastatic androgen-independent prostate cancer.

Study Status Information



Study Activation / Registration Date:	05/05/2006

IRB Review and Approval Date:	02/01/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	106 total, 53 per arm

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) A histologic or cytologic diagnosis of prostate cancer.

2) Metastatic disease that has progressed despite androgen deprivation therapy and antiandrogen withdrawal (28 days for flutamide and 42 days for bicalutamide or nilutamide). Patients must demonstrate progression base on at least one of the following criteria: a) Rising PSA (3 consecutive rises; 2 weeks between each w/minimum value of >=5 ng/mL on last), PSA value of >= 20 ng/ml within 12 months prior to randomization, 50% rise in PSA values within 6 months prior to randomization b) Progression of bidimensionally measurable soft tissue (nodal mets) c) Progression of bone disease by bone scan

3) ECOG performance status of 0-2.

4) Minimum PSA >= 5 ng/mL determined within 14 days of registration.

5) Testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.

6) No prostate cancer-related pain, no visceral metastasis (lung and/or liver).

7) No prior chemotherapy for metastatic disease. No more than one prior non-cytotoxic therapy for metastatic disease.

8) No investigational or commerical agents or therapies may be administered with the intent to treat the patient's malignancy. Four weeks must have elapsed since major surgery.

9) Prior radiotherapy is allowed as long as the bone marrow function is adequate.

10) Age >= 18 years.

11) Life expectancy of greater than 6 months.

12) Patients must have normal organ and marrow function as defined below obtained within 14 days prior to registration: WBC >= 3,000/ul, ANC >= 1,500/ul, Platelet count >= 100,000/ul, Creatinine <= 1.5 x upper limits of normal, Bilirubin within normal limits, SGOT(AST) <= 2.5 x upper limits of normal, SGPT(ALT) <= 2.5 x upper limits of normal

13) The effects of EMD 121974 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because antiangiogenic agents are known to be teratogenic, men must agree to use adequate contraception prior to study entry and for the duration of study participation.

14) Ability to understand and the willingness to sign a written informed consent document that is approved by the Institutional Human Investigation Committee (IHC).

Exclusion Criteria:

1) Patients may not be receiving any other investigational agents.

2) Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

3) Patients may continue on a daily Multi-Vitamin, but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before registration.

4) Patients on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy, that show subsequent tumor progression, may continue on this medication, however patients are not allowed to initiate bisphosphonate therapy immediately prior or during the study.

5) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

6) Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered without evidence of disease for 2 years.

Links

Registration Number: NCT00103337
Study Information on Clinical Trials Registry (clinicaltrials.gov)