Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Hormone-Resistant Prostate Cancer, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer

In brief

This phase I/II trial is studying the side effects of giving cixutumumab together with temsirolimus and to see how well it works in treating patients with metastatic prostate cancer. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may kill more tumor cells.

Key facts

Study ID: NCT01026623
Run by: National Cancer Institute (NCI)
People needed: 16
Starts: 2009-10-01
Expected to finish: 2013-02-01
Last updated by the study team: 2019-06-17

Who can join

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

You may qualify if…

Histologically or cytologically confirmed adenocarcinoma of the prostate
Distant metastases evaluable by radionuclide bone scan, CT scan, or magnetic resonance imaging (MRI) within the past 28 days
Evidence of progressive disease during androgen-deprivation therapy (including a trial of antiandrogen-withdrawal therapy), as defined by ≥ 1 of the following criteria:
Progressive measurable disease using conventional solid tumor criteria
Bone scan progression, defined as ≥ 2 new lesions on bone scan
Increasing PSA, defined as ≥ 2 consecutive rising PSA values over a reference value taken ≥ 1 week apart (the third PSA value must be greater than the second PSA value, if not, a fourth PSA value must be greater than the second PSA value)
Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL)
No known brain metastases
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
Life expectancy > 6 months
Leukocytes ≥ 3,000/μL
Absolute neutrophil count (ANC) ≥ 1,500/μL
Platelet count ≥ 100,000/μL
Hemoglobin ≥ 9 g/dL
Total bilirubin ≤ 2 times upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN
Serum creatinine ≤ 1.5 times ULN
Creatinine clearance ≥ 50 mL/min
Able to adhere to the study visit schedule and other study requirements
Fertile patients must use effective contraception before, during, and for 3 months after completion of study treatment
Adequate lung function (pulmonary function test ≥ 70% for diffusion capacity of the lung for carbon monoxide [DLco])
No poorly controlled diabetes mellitus
Patients with a history of diabetes are eligible provided their blood glucose is normal (i.e., fasting blood glucose < 120 mg/dL or < ULN) and they are on a stable dietary or therapeutic regimen
No other malignancy within the past 3 years except for treated basal cell or squamous cell carcinoma of the skin or superficial transitional cell carcinoma of the bladder
No uncontrolled major illness including, but not limited to, any of the following:

Where it is running

University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States
University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.