Cilengitide in Treating Patients With Metastatic Prostate Cancer

NCT00103337 | Completed Phase 2

• 3 other identifiers: NCI-2012-02904UMCC 2004.030N01CM62202
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial is studying how well cilengitide works in treating patients with metastatic prostate cancer. Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor

Conditions

Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical progression by bone scan or CT scan

  6 months

Secondary Outcomes (5)

• Objective response using RECIST

  Up to 30 days post-treatment

• PSA response based on recommendations from the PSA Working Group

  Up to 30 days post-treatment

• Time to clinical response

  Up to 30 days post-treatment

• Time to PSA response

  Up to 30 days post-treatment

• Incidence of toxicity as assessed by CTCAE v3.0

  Up to 30 days post-treatment

Study Arms (2)

Arm I (500 mg cilengitide)

EXPERIMENTAL

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

Drug: cilengitide; Other: laboratory biomarker analysis

Arm II (2000 mg cilengitide)

EXPERIMENTAL

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

Drug: cilengitide; Other: laboratory biomarker analysis

Interventions

cilengitide DRUG

Given IV

Also known as: EMD 121974

Arm I (500 mg cilengitide); Arm II (2000 mg cilengitide)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (500 mg cilengitide); Arm II (2000 mg cilengitide)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A histologic or cytologic diagnosis of prostate cancer
• 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 based on at least one of the following criteria:
• Rising PSA - Defined as by one of the following criteria:
• Three consecutive rising levels, with an interval of at least 2 weeks between each determination; the last determination must have a minimum value of \>= 5 ng/ml and be determined within two weeks prior to registration
• A PSA value of \>= 20 ng/ml obtained within the 12 months prior to randomization and confirmed within 2 weeks prior to registration
• A 50% rise in PSA values within 6 months prior to registration and confirmed within 2 weeks prior to registration; the last determination must have a minimum value of \>= 5 ng/ml
• Progression of bidimensionally measurable soft tissue (nodal metastasis) assessed within 28 days prior to registration by a CT scan or MRI of the abdomen and pelvis
• Progression of bone disease (evaluable disease) (new bone lesion(s)) by bone scan within 42 days prior to registration
• ECOG performance status of 0-2
• Minimum PSA \>= 5 ng/mL determined within 14 days of registration
• Testosterone \< 50 ng/dL; patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy
• Patients must have no prostate cancer-related pain, and no visceral metastasis (lung and/or liver)
• No prior chemotherapy for metastatic disease; no more than one prior non-cytotoxic therapy for metastatic disease
• No investigational or commercial agents or therapies may be administered with the intent to treat the patient's malignancy; four weeks must have elapsed since major surgery
• Prior radiotherapy is allowed as long as the bone marrow function is adequate

You may not qualify if:

• Patients may not be receiving any other investigational agents
• 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
• 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
• 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
• 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
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Michigan University Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cilengitide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Maha Hussain

  University of Michigan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: January 1, 2005
• Primary Completion: October 1, 2007
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

US (1)