Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00953576
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ketoconazole — DRUG
  • hydrocortisone — DRUG
  • dutasteride — DRUG
  • lapatinib — DRUG

Study Details

The purpose of this research study is to determine the safety of giving ketoconazole, hydrocortisone and dutasteride (KHAD) with lapatinib. Safety is primarily based on dose limiting toxicity (DLT) evaluation at various dose levels (DL). The investigators believe that there is evidence in castrate resistant prostate cancer (CRPC) that two growth factor receptors (EGFR and Her 2/Neu) are increased in prostate cancer (PCa) cells. Both these receptors are turned off by the drug lapatinib. By adding lapatinib, the investigators hope that signaling from the receptors will be turned off and therefore make the participant's cancer more responsive to KHAD treatment.

Key Dates

Start date
Sep 29, 2009
Status verified
Jul 2018
Primary completion
Apr 11, 2013
Completion
Apr 11, 2013

Study Design

Enrollment
11 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose Level 1 (DL1): KHAD+L (250 mg)
    For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment. Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day Participants are treated until unacceptable toxicity, disease progression or withdrawal.
  • Experimental: Phase I Dose Level 2 (DL2): KHAD+L (500 mg)
    For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment. Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day
  • Experimental: All Phase I Participants
    For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment. Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: according to the established dose escalation schedule Participants are treated until unacceptable toxicity, disease progression or withdrawal.

Primary Outcome Measure

Lapatinib Maximum Tolerated Dose (MTD) [Phase I] [ Time Frame: The evaluation for MTD occurred continuously through one cycle of KHLAD treatment (28 days). ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MA

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