Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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:

• Active infection, including human immunodeficiency virus (HIV) infection or viral hepatitis

• Symptomatic congestive heart failure (class III or IV)

• Unstable angina pectoris

• Myocardial infarction or acute coronary syndrome within the past year

• Serious cardiac arrhythmia

• Significant lung disease

• Major psychiatric illness

• No other concurrent anticancer agents or treatments

• No prior chemotherapy, except for neoadjuvant chemotherapy

• No prior anti-insulin-like growth factor receptor (IGFR) agents or mammalian target of rapamycin (mTOR) inhibitors

• No prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy

• Prior standard-dose radiotherapy to the pelvis for prostate cancer and/or additional external-beam radiotherapy to metastatic sites allowed

• More than 4 weeks since prior surgery, radiotherapy, combined androgen blockade (excluding single-agent gonadotropin releasing-hormone agonists/antagonists), or investigational therapies

• No concurrent second-line hormonal agents, including ketoconazole, diethylstilbestrol, other estrogen-like agents, or finasteride

• No concurrent corticosteroids unless patient is on a stable maintenance dose of hydrocortisone (≤ 30 mg/day) for ≥ 3 months