Trial Outcomes & Findings for Lenalidomide and Cyclophosphamide in Treating Patients With Previously Treated Hormone-Refractory Prostate Cancer (NCT NCT01093183)

NCT ID: NCT01093183

Last Updated: 2023-09-13

Results Overview

Defined to be the dose cohort below which 2 of 3 or 3 of 6 patients experience dose-limiting toxicities in course 1 or the highest dose cohort of 25 mg.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2023-09-13

Participant Flow

Participant milestones

Measure	Phase I Treatment (Lenalidomide and Cyclophosphamide) Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response. lenalidomide and cyclophosphamide: Given PO	Phase II Treatment (Lenalidomide and Cyclophosphamide) Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response. lenalidomide and cyclophosphamide: Given PO
Overall Study STARTED	19	6
Overall Study COMPLETED	18	4
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lenalidomide and Cyclophosphamide in Treating Patients With Previously Treated Hormone-Refractory Prostate Cancer

Baseline characteristics by cohort

Measure	Treatment (Lenalidomide and Cyclophosphamide) n=25 Participants Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response. lenalidomide and cyclophosphamide: Given PO
Age, Continuous	76 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Defined to be the dose cohort below which 2 of 3 or 3 of 6 patients experience dose-limiting toxicities in course 1 or the highest dose cohort of 25 mg.

Outcome measures

Measure	Treatment (Lenalidomide and Cyclophosphamide) n=19 Participants Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response. lenalidomide and cyclophosphamide: Given PO
Maximum Tolerated Dose of Lenalidomide Administered in Combination With Oral Cyclophosphamide (Phase I)	25 mg

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Treatment (Lenalidomide and Cyclophosphamide) n=22 Participants Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response. lenalidomide and cyclophosphamide: Given PO
Number of Patients Achieving Objective PSA Response (50% Decrease in PSA Levels Sustained for at Least 4 Weeks) as Defined by PSA Working Group Criteria	7 Participants

SECONDARY outcome

Timeframe: Up to 4 months

Population: Of the 22 subjects evaluable, three patients did not complete 2 cycles of therapy to reassess or response evaluation.

As measured by Response Evaluation Criteria In Solid Tumors (RECIST version 1.1), in which CR is defined as disappearance of target lesions and a partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions. PD is defined as 20% increase over smallest sum on study (including baseline if that is smallest) and at least 5 mm increase or new lesions. SD is defined as not enough response to be PR and not enough progression to be PD.

Outcome measures

Measure	Treatment (Lenalidomide and Cyclophosphamide) n=22 Participants Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response. lenalidomide and cyclophosphamide: Given PO
Anti-tumor Activity as Assessed by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Stable disease	15 Participants
Anti-tumor Activity as Assessed by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) partial response	7 Participants

SECONDARY outcome

Timeframe: At 4 months

Outcome measures

Measure	Treatment (Lenalidomide and Cyclophosphamide) n=22 Participants Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response. lenalidomide and cyclophosphamide: Given PO
Proportion of Patients Achieving CR	0 Participants

SECONDARY outcome

Timeframe: Up to 4 years

Outcome measures

Measure	Treatment (Lenalidomide and Cyclophosphamide) n=25 Participants Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response. lenalidomide and cyclophosphamide: Given PO
Overall Survival	20 months Interval 13.0 to 24.0

Adverse Events

Treatment (Lenalidomide and Cyclophosphamide)

Serious events: 6 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Lenalidomide and Cyclophosphamide) n=25 participants at risk Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response. lenalidomide and cyclophosphamide: Given PO
Blood and lymphatic system disorders Leukopenia	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Blood and lymphatic system disorders Neutropenia	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Blood and lymphatic system disorders Thrombocytopenia	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Vascular disorders Hypotension	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Gastrointestinal disorders Abdominal Pain	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Nervous system disorders Vasovagal episode	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Nervous system disorders Syncope	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Blood and lymphatic system disorders Anemia	4.0% 1/25 • Number of events 2 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Blood and lymphatic system disorders Febrile Neutropenia	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Infections and infestations Lung Infection	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.

Other adverse events

Measure	Treatment (Lenalidomide and Cyclophosphamide) n=25 participants at risk Patients receive lenalidomide PO QD on days 1-21 and cyclophosphamide PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response. lenalidomide and cyclophosphamide: Given PO
General disorders Fatigue	16.0% 4/25 • Number of events 4 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Metabolism and nutrition disorders Hypokalemia	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Blood and lymphatic system disorders Neutropenia	24.0% 6/25 • Number of events 13 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Blood and lymphatic system disorders Leukopenia	16.0% 4/25 • Number of events 9 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Metabolism and nutrition disorders Hypophosphatemia	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Blood and lymphatic system disorders Thrombocytopenia	12.0% 3/25 • Number of events 5 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.
Investigations Alkaline Phosphatase Increased	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time the first patient enrolled through when the last patient completed study treatment.

Additional Information

James Schwarz, MD

University of Nebraska Medical Center

Phone: 402-559-5166

Email: jkschwarz@unmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place