Trial Outcomes & Findings for Cilengitide in Treating Patients With Prostate Cancer (NCT NCT00121238)
NCT ID: NCT00121238
Last Updated: 2016-04-28
Results Overview
To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer. This measure defined as a drop in PSA of at least 50% from the final pre-treatment value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2016-04-28
Participant Flow
16 patients were registered to the protocol at 6 centers between January 2005 and May 2007.
1 patient progressed clinically before any treatment and was not included in toxicity or efficacy endpoint analysis. Two patients who received drug were deemed ineligible because of PSA rise requirement and withdrawn for analysis for efficacy but their data was entered into toxicity analysis
Participant milestones
| Measure |
Drug Treatment (Cilengitide)
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.
cilengitide : Given IV
Experimental drug treatment : Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Drug Treatment (Cilengitide)
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.
cilengitide : Given IV
Experimental drug treatment : Correlative studies
|
|---|---|
|
Overall Study
disease progression before intervention
|
1
|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Cilengitide in Treating Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Drug Treatment (Cilengitide)
n=13 Participants
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.
cilengitide : Given IV
Experimental drug treatment : Correlative studies
|
|---|---|
|
Age, Customized
age in years
|
65.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
|
Prostate Specific Antigen (PSA)
|
8.4 ng/mL
n=5 Participants
|
|
Gleason sum
Gleason sum 6
|
2 participants
n=5 Participants
|
|
Gleason sum
Gleason sum 7
|
6 participants
n=5 Participants
|
|
Gleason sum
Gleason sum 8
|
2 participants
n=5 Participants
|
|
Gleason sum
Gleason sum 9
|
3 participants
n=5 Participants
|
|
Karnofsky Performance Score
|
90 units on a scale
n=5 Participants
|
|
Prior radiation to prostate
Definitive
|
5 participants
n=5 Participants
|
|
Prior radiation to prostate
Adjuvant
|
3 participants
n=5 Participants
|
|
Prior radiation to prostate
Salvage
|
3 participants
n=5 Participants
|
|
Radical Prostatectomy
|
6 participants
n=5 Participants
|
|
No Local Treatment Modality
|
2 participants
n=5 Participants
|
|
Median time since ADT initiation
|
4.7 years
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Per protocol: of the 16 patients registered for this arm, 13 were analyzed. 1 patient lost eligibility due to disease progression, 2 others were censored from efficacy analysis because it was determined they were ineligible based on PSA requirements.
To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer. This measure defined as a drop in PSA of at least 50% from the final pre-treatment value.
Outcome measures
| Measure |
Drug Treatment (Cilengitide)
n=13 Participants
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.
cilengitide : Given IV
Experimental drug treatment : Correlative studies
|
|---|---|
|
The Number of Patients With a PSA Decline of ≥50%
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsMedian PSA slope difference was calculated between baseline and 6 months.
Outcome measures
| Measure |
Drug Treatment (Cilengitide)
n=13 Participants
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.
cilengitide : Given IV
Experimental drug treatment : Correlative studies
|
|---|---|
|
Median PSA Slope Difference
|
0.9 ng/mL/month
Interval -0.97 to 4.11
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All treated patients, including 2 patients who were deemed ineligible for the study's endpoints to measure efficacy.
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients (16 patients were enrolled however one progressed prior to treatment) including the two ineligible patients.
Outcome measures
| Measure |
Drug Treatment (Cilengitide)
n=15 Participants
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.
cilengitide : Given IV
Experimental drug treatment : Correlative studies
|
|---|---|
|
The Number of Participants With at Least One Incident of Toxicity
|
15 participants
|
SECONDARY outcome
Timeframe: Up to 5 years6 of 13 patients were alive at five years. The Median survival time was calculated for all patients.
Outcome measures
| Measure |
Drug Treatment (Cilengitide)
n=13 Participants
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.
cilengitide : Given IV
Experimental drug treatment : Correlative studies
|
|---|---|
|
Median Survival Time
|
34.5 months
Interval 27.4 to
The upper limit has not yet been reached.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients were eligible if they had a histologic or cytologic diagnosis of prostate cancer with no evidence of metastatic disease or local progression on radiologic imaging and had 3 consecutive rising levels of prostate specific antigen (psa). Eligible patients who were treated on this trial were analyzed for survival
Kaplan-Meier estimates of time to progression will be reported.
Outcome measures
| Measure |
Drug Treatment (Cilengitide)
n=13 Participants
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.
cilengitide : Given IV
Experimental drug treatment : Correlative studies
|
|---|---|
|
Mean Time to Progression of Prostate Cancer
|
1.8 months
Interval 0.9 to 2.8
|
Adverse Events
Drug Treatment (Cilengitide)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug Treatment (Cilengitide)
n=15 participants at risk
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.
cilengitide : Given IV
Experimental drug treatment : Correlative studies
|
|---|---|
|
Cardiac disorders
atrial fibrillation
|
13.3%
2/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
Other adverse events
| Measure |
Drug Treatment (Cilengitide)
n=15 participants at risk
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.
cilengitide : Given IV
Experimental drug treatment : Correlative studies
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis (Gr1)
|
13.3%
2/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Blood and lymphatic system disorders
Increased aspartate aminotransferase (Gr1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Gastrointestinal disorders
Constipation (Gr1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Gastrointestinal disorders
Diarrhea (Gr1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Eye disorders
Dry eye syndrome (Gr1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
General disorders
Edema (Gr.1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
General disorders
Fatigue (Gr.1)
|
26.7%
4/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
General disorders
Flushing (Gr1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
General disorders
Headache (Gr.1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Blood and lymphatic system disorders
Decreased hemoglobin (gr1)
|
13.3%
2/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia NOS (Gr.1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia (Gr.1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
General disorders
Hyponatremia (Gr.1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Nervous system disorders
Memory impairment (Gr.1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Gastrointestinal disorders
Nausea Gr 1
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash (desquamating) (Gr.1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Gastrointestinal disorders
Toothache (Gr.1)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Gr.2)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Blood and lymphatic system disorders
Lymphopenia (Gr.2)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (Gr.2)
|
6.7%
1/15 • During treatment with study drug for 1 year if toxicity did not halt treatment
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients including the 2 ineligible patients. No Grade 4 events,2 grade 3 events, 3 grade 2 events and 22 grade 1 adverse events.
|
Additional Information
Maha Hussain, M.D.
University of Michigan Comprehensive Cancer Center
Phone: (734)936-8906
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60