Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostatic Neoplasms

In brief

The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.

Key facts

Study ID

NCT00744497

Run by

Bristol-Myers Squibb

People needed

1930

Starts

2008-10-01

Expected to finish

2015-07-01

Last updated by the study team

2016-10-17

Who can join

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

You may qualify if…

• History of histologically diagnosed prostate cancer
• Evidence of metastatic disease by any 1 of the following: computed tomography scan, magnetic resonance imaging, bone scan, or skeletal survey
• Evidence of progression, as defined by 1 of the following: rising prostate specific antigen levels at least 1 week apart with the final value being >=2 ng/mL; progression of measurable nodal or visceral disease, with nodal lesions >=20 mm and visceral lesions measurable per response evaluation criteria for solid tumors (Response Evaluation in Solid Tumors, version 1); 2 or more lesions appearing on bone scan compared with previous scan; or local recurrence in the prostate or prostate bed
• Maintaining castrate status: Participants who have not undergone surgical orchiectomy should have received and continue on medical therapies, such as gonadotropin releasing hormone analogs, to maintain castrate levels of serum testosterone <=50 ng/dL
• Eastern Cooperative Oncology Group Performance Status of 0 to 2
• At least 4 weeks since an investigational agent prior to starting study therapy
• At least 8 weeks since radioisotope therapy prior to starting study therapy
• Recovery from any local therapy including surgery or radiation/radiotherapy for a minimum of 7 days prior to starting study therapy
• Required initial laboratory values: white blood cell count >=3,000/mm\^3; absolute neutrophil count >=1,500/mm\^3; platelet count >=100,000/mm\^3; creatinine level <=1.5*upper limit of normal (ULN); bilirubin <=ULN; aspartate aminotransferase <=2.5*ULN; alanine aminotransferase <=2.5*ULN.

You may not qualify if…

• Symptomatic brain metastases or leptomeningeal metastases
• Clinically significant cardiovascular disease, including myocardial infarction; ventricular tachyarrhythmia within 6 months; prolonged QTc >450 msec; ejection fraction <40%; or major conduction abnormality, unless a cardiac pacemaker is present
• Pleural or pericardial effusion of any Common Terminology Criteria (CTC) grade
• Peripheral neuropathy CTC Grade >=2
• Currently active second malignancy other than nonmelanoma skin cancers. Participants are not considered to have a currently active malignancy if they have completed therapy and are now considered (by their physician) to be at less than 30% risk for relapse
• Uncontrolled intercurrent illness including ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• HIV infection-positive patients receiving combination antiretroviral therapy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the investigational agents
• Receipt of any other investigational agents for the treatment of prostate cancer
• Prior cytotoxic chemotherapy in the metastatic setting, with the exception of estramustine
• Patients may continue on a daily multivitamin but must discontinue all other herbal, alternative, and food supplements before enrollment
• Ketoconazole must be discontinued 4 weeks prior to starting study therapy
• Antiandrogens must be discontinued prior to starting study therapy. Patients with a history of response to an antiandrogen and subsequent progression while on that antiandrogen should be assessed for antiandrogen withdrawal response for 4 weeks. Observation for antiandrogen withdrawal response is not necessary for those who have never responded to antiandrogens
• Bisphosphonates must not be initiated within 28 days prior to starting study therapy
• QT prolonging agents strongly associated with torsade de pointes.

Where it is running

• Southern Cancer Center — Mobile, Alabama, United States
• Alaska Clinical Research Center, Llc — Anchorage, Alaska, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Compassionate Cancer Care Medical Group, Inc. — Corona, California, United States
• Desert Hematology Oncology Medical Group — Rancho Mirage, California, United States
• Compassionate Cancer Care Medical Group Inc — Riverside, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• Va San Diego Healthcare System — San Diego, California, United States
• Edward Alexson, Md, Inc. — Santa Ana, California, United States
• Connecticut Oncology Group — Middletown, Connecticut, United States
• Va Connecticut Healthcare System — West Haven, Connecticut, United States
• Gwinnett Hospital System Inc. — Lawrenceville, Georgia, United States
• University Of Chicago — Chicago, Illinois, United States
• Midwestern Regional Medical Center — Zion, Illinois, United States
• Fort Wayne Medical Oncology And Hematology Inc — Fort Wayne, Indiana, United States
• Cancer Center Of Kansas — Wichita, Kansas, United States
• Maine Center For Cancer Medicine — Scarborough, Maine, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Jackson Oncology Associates, Pllc — Jackson, Mississippi, United States
• North Mississippi Hematology And Oncology Associates, Ltd — Tupelo, Mississippi, United States
• New York Oncology Hematology, Pc — Albany, New York, United States
• New York Oncology Hematology, Pc — Albany, New York, United States
• Samuel S. Stratton Vamc — Albany, New York, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• University Of South Alabama / Mitchell Cancer Institute — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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