Status:
COMPLETED
Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
1930 Patients enrolled
Trial Details
Trial ID
NCT00744497
Start Date
October 1 2008
End Date
July 1 2015
Last Update
October 17 2016
Active Locations (186)
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1
University Of South Alabama / Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
2
Southern Cancer Center
Mobile, Alabama, United States, 36608
3
Alaska Clinical Research Center, Llc
Anchorage, Alaska, United States, 99508
4
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703