A Study of IMC-A12 or Ramucirumab Plus Mitoxantrone and Prednisone in Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to determine whether IMC-A12 or IMC-1121B (ramucirumab) with Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent prostate cancer (APIC).

Key facts

Study ID

NCT00683475

Run by

Eli Lilly and Company

People needed

138

Starts

2008-08-01

Expected to finish

2011-09-01

Last updated by the study team

2014-10-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• The participant has histologically-confirmed adenocarcinoma of the prostate
• The participant has radiographic evidence of metastatic prostate cancer (stage M1 or D2)
• The participant has prostate cancer unresponsive or refractory to hormone therapy (androgen-independent)
• The participant has had disease progression (clinical or radiographic) while receiving docetaxel, or within 120 days of receiving docetaxel-based chemotherapy and in the opinion of the investigator is unlikely to derive significant benefit from additional docetaxel-based therapy, or was intolerant to therapy with this agent
• The participant must have evidence of progressive disease defined as at least one of the following;
• Progressive measurable disease: using conventional solid tumor criteria
• Bone scan progression: at least two new lesions on bone scan
• Increasing PSA: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2
• The participant has a PSA ≥ 2 ng/mL
• The participant has prior surgical or medical castration with a serum testosterone of <50 ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the participant must be willing to continue the use of LHRH agonists during protocol treatment
• The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2
• The participant has adequate hematologic function (absolute neutrophil count [ANC]≥1500/uL, hemoglobin ≥9 g/dL, and platelets ≥100,000/uL)
• The participant has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of normal (ULN), Aspartate Transaminase (AST) and Alanine Transaminase (ALT) ≤ 3 times the ULN, or ≤ 5 times the ULN if liver metastases are present)
• The participant has adequate renal function (creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 40 mL/min)
• The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
• The participant has adequate coagulation function (an international normalized ratio [INR] ≤ 1.5 and a Partial Thromboplastin Time [PTT] ≤ 5 seconds above the ULN [unless on oral anticoagulant therapy]). Participants receiving full-dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (and if on warfarin have a therapeutic INR between 2 and 3)
• The participant has a fasting serum glucose level of < 160 mg/dL, or below the ULN

You may not qualify if…

• The participant has received more than one prior cytotoxic chemotherapy regimen for metastatic disease. (Participants who have had a treatment break followed by a second docetaxel-based regimen with subsequent disease progression are eligible.)
• The participant has received prior therapy with mitoxantrone for advanced prostate cancer (prior adjuvant therapy with mitoxantrone is permitted)
• The participant has a history of symptomatic congestive heart failure or has a pre-study echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) that is ≥ 10% below the LLN
• The participant has received radiotherapy ≤ 21 days prior to first dose of IMC-A12 or Ramucirumab
• The participant is receiving corticosteroids (dexamethasone, prednisone, or others) at a dose > 5 mg prednisone orally (PO) two times per day (BID) or equivalent. Participants receiving corticosteroids at higher doses may be eligible if their corticosteroid therapy is tapered to study levels (prednisone 5 mg PO BID) prior to first dose of study medication, without concomitant clinical deterioration
• The participant has known or suspected brain or leptomeningeal metastases
• The participant has uncontrolled or poorly controlled hypertension
• The participant has poorly controlled diabetes mellitus. Inclusion Criteria:
• The participant has histologically-confirmed adenocarcinoma of the prostate
• The participant has radiographic evidence of metastatic prostate cancer (stage M1 or D2)
• The participant has prostate cancer unresponsive or refractory to hormone therapy (androgen-independent)
• The participant has had disease progression (clinical or radiographic) while receiving docetaxel, or within 120 days of receiving docetaxel-based chemotherapy and in the opinion of the investigator is unlikely to derive significant benefit from additional docetaxel-based therapy, or was intolerant to therapy with this agent
• The participant must have evidence of progressive disease defined as at least one of the following;
• Progressive measurable disease: using conventional solid tumor criteria
• Bone scan progression: at least two new lesions on bone scan
• Increasing PSA: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2
• The participant has a PSA ≥ 2 ng/mL
• The participant has prior surgical or medical castration with a serum testosterone of <50 ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the participant must be willing to continue the use of LHRH agonists during protocol treatment
• The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2
• The participant has adequate hematologic function (absolute neutrophil count [ANC]≥1500/uL, hemoglobin ≥9 g/dL, and platelets ≥100,000/uL)
• The participant has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase [AST] and alanine transaminase [ALT]≤ 3 times the ULN, or ≤ 5 times the ULN if liver metastases are present)
• The participant has adequate renal function (creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 40 mL/min)
• The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
• The participant has adequate coagulation function (an international normalized ratio [INR] ≤ 1.5 and a partial thromboplastin time [PTT] ≤ 5 seconds above the ULN [unless on oral anticoagulant therapy]). Participants receiving full-dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (and if on warfarin have a therapeutic INR between 2 and 3)
• The participant has a fasting serum glucose level of < 160 mg/dL, or below the ULN

Where it is running

• ImClone Investigational Site — La Jolla, California, United States
• ImClone Investigational Site — New Haven, Connecticut, United States
• ImClone Investigational Site — Boca Raton, Florida, United States
• ImClone Investigational Site — Port Saint Lucie, Florida, United States
• ImClone Investigational Site — Atlanta, Georgia, United States
• ImClone Investigational Site — Chicago, Illinois, United States
• ImClone Investigational Site — Chlcago, Illinois, United States
• ImClone Investigational Site — Evanston, Illinois, United States
• ImClone Investigational Site — Maryville, Illinois, United States
• ImClone Investigational Site — Cedar Rapids, Iowa, United States
• ImClone Investigational Site — Metairie, Louisiana, United States
• ImClone Investigational Site — Ann Arbor, Michigan, United States
• ImClone Investigational Site — Rochester, Minnesota, United States
• ImClone Investigational Site — St Louis, Missouri, United States
• ImClone Investigational Site — Billings, Montana, United States
• ImClone Investigational Site — Roseland, New Jersey, United States
• ImClone Investigational Site — Buffalo, New York, United States
• ImClone Investigational Site — East Setauket, New York, United States
• ImClone Investigational Site — New York, New York, United States
• ImClone Investigational Site — New York, New York, United States
• ImClone Investigational Site — New York, New York, United States
• ImClone Investigational Site — New York, New York, United States
• ImClone Investigational Site — Durham, North Carolina, United States
• ImClone Investigational Site — Cleveland, Ohio, United States
• ImClone Investigational Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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