Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2013-01-31

Brief Summary

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The purpose of this study is to find the recommended doses of dasatinib and docetaxel given in combination to men with metastatic hormone refractory prostate cancer and to assess the pharmacokinetic interactions between the 2 drugs.

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Detailed Description

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Conditions

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Metastatic Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dasatinib, 50 mg + Docetaxel, 60 mg/m^2

Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m\^2.

Group Type ACTIVE_COMPARATOR

Dasatinib

Intervention Type DRUG

Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression

Docetaxel

Intervention Type DRUG

Infusion, 60 or 75 mg/m\^2, administered every 3 weeks.

Dasatinib, 50 mg + Doxetaxel, 75 mg/m^2

Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.

Group Type ACTIVE_COMPARATOR

Dasatinib

Intervention Type DRUG

Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression

Docetaxel

Intervention Type DRUG

Infusion, 60 or 75 mg/m\^2, administered every 3 weeks.

Dasatinib, 70 mg + Docetaxel, 75 mg/m^2

Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.

Group Type ACTIVE_COMPARATOR

Dasatinib

Intervention Type DRUG

Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression

Docetaxel

Intervention Type DRUG

Infusion, 60 or 75 mg/m\^2, administered every 3 weeks.

Dasatinib, 100 mg + Docetaxel, 75 mg/m^2

Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.

Group Type ACTIVE_COMPARATOR

Dasatinib

Intervention Type DRUG

Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression

Docetaxel

Intervention Type DRUG

Infusion, 60 or 75 mg/m\^2, administered every 3 weeks.

Dasatinib, 120 mg + Docetaxel, 75 mg/m^2

Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.

Group Type ACTIVE_COMPARATOR

Dasatinib

Intervention Type DRUG

Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression

Docetaxel

Intervention Type DRUG

Infusion, 60 or 75 mg/m\^2, administered every 3 weeks.

Interventions

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Dasatinib

Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression

Intervention Type DRUG

Docetaxel

Infusion, 60 or 75 mg/m\^2, administered every 3 weeks.

Intervention Type DRUG

Other Intervention Names

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Sprycel BMS-354825

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed adenocarcinoma of the prostate that was clinically refractory to hormone therapy
* Eastern Cooperative Oncology Group performance status of 0 - 2
* Evidence of progressive metastatic disease at time of enrollment
* Measurable disease on either computer tomography scan or magnetic resonance imaging or positive bone scan with any level of serum prostate specific antigen (PSA) ≥5 ng/ml. Patients with PSA ≥5 ng/ml only and no other radiographic evidence of metastatic prostate cancer were not eligible
* Evidence of progressive disease since the most recent change in therapy. Progressive disease was defined as any one of the following:

* Objective disease progression: Objective evidence of increase in radiographic lesions or the appearance of 1 or more new lesions
* Bone scan progression: Appearance of either of the following: 2 or more new lesions on bone scan attributable to prostate cancer or 1 new lesion on bone scan attributable to prostate cancer in conjunction with a rising PSA
* PSA progression: 2 consecutively rising PSA levels (≥5 ng/mL) separated by 2 weeks with a testosterone concentration of ≤50 ng/dL at 2 week intervals
* Serum testosterone levels ≤50 ng/dL, determined within 2 weeks prior to starting treatment
* Maintaining castrate status: patients who had not undergone surgical orchiectomy must have continued on medical therapies, such as gonadotropin-releasing hormone analogs, to maintain castrate levels of serum testosterone. Those receiving an antiandrogen as part of their first-line hormonal therapy must have shown progression of disease off of the antiandrogen prior to enrollment (6 weeks withdrawal for bicalutamide; 4 weeks for flutamide)

Exclusion Criteria

* Sexually active fertile men not using effective birth control if their partners were women of child-bearing potential
* Known brain metastases
* Clinically-significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia within 6 months; prolonged heart rate-corrected QT interval (QTc) \>450 msec; ejection fraction \<40%, or major conduction abnormality (unless a cardiac pacemaker was present)
* Pleural or pericardial effusion, due to concerns that the combination of docetaxel and dasatinib could worsen these events
* Uncontrolled intercurrent illness including, ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that limit compliance with study requirements
* Participants were permitted to continue on a daily multivitamin but all other herbal, alternative, and food supplements must have been discontinued before enrollment into the study
* Ketoconazole must have been discontinued 4 weeks prior to enrollment
* Patients were not permitted to receive radioactive bone targeting agents, such as Strontium or Samarian ,while on study treatment
* The following restrictions on prior therapy for metastatic disease applied:

* One chemotherapy regimen was permitted as long as docetaxel resistance or intolerance was not demonstrated. Docetaxel resistance was defined as objective disease progression or confirmed PSA progression during docetaxel therapy or within 3 months of treatment completion. Docetaxel intolerance was defined as toxicity requiring docetaxel interruption \>4 weeks or dose modification below approved doses
* No more than 1 prior course of palliative radiotherapy
* Up to 1 prior treatment with a nonchemotherapeutic agent was permitted as treatment for metastatic prostate cancer
* No prior radioisotope therapy with Strontium-89, Samarium, or similar agents
* No limitation on prior hormonal therapy
* QTc prolonging agents strongly associated with Torsade de Pointes arrhythmia

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No