Docetaxel (Taxotere) and Imatinib Mesylate (Gleevec) in Hormone Refractory Prostate Cancer

This study has been terminated.

(due to slow accrual)

Sponsor:

Collaborator:

Novartis

Information provided by:

New York University School of Medicine

ClinicalTrials.gov Identifier:

NCT00861471

First received: March 12, 2009

Last updated: August 17, 2011

Last verified: August 2011

History of Changes

Results First Received: April 29, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Prostate Cancer Prostatic Neoplasms
Interventions:	Drug: Docetaxel Drug: Imatinib Mesylate

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
12 patients were enrolled between Sep. 2006 and Nov. 2008 for the Phase II part of the study in New York University Medical center and affiliated hospitals.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Once the optimal combination dose of Docetaxel (Taxotere) and Gleevec (Imatinib Mesylate) was determined in the Phase I part, the study proceeded to Phase II. There were 12 patients in Phase I and Phase II, respectively. The results reported here are only for Phase II.

Reporting Groups

	Description
Docetaxel +Gleevec	21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days

Participant Flow: Overall Study

	Docetaxel +Gleevec
STARTED	12
COMPLETED	3
NOT COMPLETED	9
Withdrawal by Subject	1
Adverse Event	2
Lack of Efficacy	3
treatment for lumbar laminectomy	1
Physician Decision	2

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Docetaxel +Gleevec	21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days

Baseline Measures

	Docetaxel +Gleevec
Number of Participants [units: participants]	12
Age [units: participants]
<=18 years	0
Between 18 and 65 years	5
>=65 years	7
Age [units: years] Mean ± Standard Deviation	67.2 ± 9.9
Gender [units: participants]
Female	0
Male	12
Region of Enrollment [units: participants]
United States	12

Outcome Measures

Show All Outcome Measures

1. Primary:

Percentage of Participants With Prostate Specific Antigen (PSA) Response [ Time Frame: up to 9 months ]

Show Outcome Measure 1

2. Secondary:

Percentage of Participants With Greater or Equal to 80% PSA Reduction From Baseline Without Clinical or Radiologic Evidence of Progression [ Time Frame: up to 9 months ]

Show Outcome Measure 2

3. Secondary:

Percentage of Participants With Measurable Disease Response [ Time Frame: up to 2 years ]

Show Outcome Measure 3

4. Secondary:

Time to PSA Progression [ Time Frame: up to 2 years ]

Show Outcome Measure 4

5. Secondary:

Median Overall Survival Time [ Time Frame: up to 4 years ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Hide Other Adverse Events

Time Frame	on study (up to 9 months) plus 30 days after
Additional Description	adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Docetaxel +Gleevec	21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days

Other Adverse Events

	Docetaxel +Gleevec
Total, other (not including serious) adverse events
# participants affected / at risk	12/12
Blood and lymphatic system disorders
hemoglobin ^{† 1}
# participants affected / at risk	8/12 (66.67%)
leukocytes ^{† 1}
# participants affected / at risk	1/12 (8.33%)
lymphatics ^{† 1}
# participants affected / at risk	3/12 (25.00%)
neutrophils/ granulocytes ^{† 1}
# participants affected / at risk	2/12 (16.67%)
platelets ^{† 1}
# participants affected / at risk	1/12 (8.33%)
Cardiac disorders
edema ^{† 1}
# participants affected / at risk	5/12 (41.67%)
palpitations ^{† 1}
# participants affected / at risk	1/12 (8.33%)
sinus tachycardia ^{† 1}
# participants affected / at risk	1/12 (8.33%)
Eye disorders
ocular/ visual -other ^{† 1}
# participants affected / at risk	3/12 (25.00%)
tearing ^{† 1}
# participants affected / at risk	3/12 (25.00%)
Gastrointestinal disorders
anorexia ^{† 1}
# participants affected / at risk	4/12 (33.33%)
constipation ^{† 1}
# participants affected / at risk	4/12 (33.33%)
dehydration ^{† 1}
# participants affected / at risk	1/12 (8.33%)
diarrhea (with colostomy) ^{† 1}
# participants affected / at risk	1/12 (8.33%)
diarrhea (without colostomy) ^{† 1}
# participants affected / at risk	5/12 (41.67%)
gastrointestinal- other ^{† 1}
# participants affected / at risk	1/12 (8.33%)
nausea ^{† 1}
# participants affected / at risk	7/12 (58.33%)
stomatitis/ pharyngitis ^{† 1}
# participants affected / at risk	1/12 (8.33%)
taste disturbance ^{† 1}
# participants affected / at risk	4/12 (33.33%)
vomiting ^{† 1}
# participants affected / at risk	3/12 (25.00%)
General disorders
abdominal pain or cramping ^{† 1}
# participants affected / at risk	2/12 (16.67%)
constitutioanl symptoms-other ^{† 1}
# participants affected / at risk	1/12 (8.33%)
fatigue ^{† 1}
# participants affected / at risk	9/12 (75.00%)
fever ^{† 1}
# participants affected / at risk	1/12 (8.33%)
pain -other ^{† 1}
# participants affected / at risk	3/12 (25.00%)
rigors/ chills ^{† 1}
# participants affected / at risk	1/12 (8.33%)
weight gain ^{† 1}
# participants affected / at risk	1/12 (8.33%)
weight loss ^{† 1}
# participants affected / at risk	1/12 (8.33%)
Immune system disorders
allergic rhinitis ^{† 1}
# participants affected / at risk	1/12 (8.33%)
Metabolism and nutrition disorders
hyponatremia ^{† 1}
# participants affected / at risk	1/12 (8.33%)
Musculoskeletal and connective tissue disorders
bone pain ^{† 1}
# participants affected / at risk	1/12 (8.33%)
myalgia ^{† 1}
# participants affected / at risk	2/12 (16.67%)
Nervous system disorders
insomnia ^{† 1}
# participants affected / at risk	1/12 (8.33%)
neuropathy /sensory ^{† 1}
# participants affected / at risk	7/12 (58.33%)
Respiratory, thoracic and mediastinal disorders
cough ^{† 1}
# participants affected / at risk	2/12 (16.67%)
dyspnea ^{† 1}
# participants affected / at risk	5/12 (41.67%)
Skin and subcutaneous tissue disorders
alopecia ^{† 1}
# participants affected / at risk	5/12 (41.67%)
dermotology/ skin- other ^{† 1}
# participants affected / at risk	4/12 (33.33%)
dry skin ^{† 1}
# participants affected / at risk	2/12 (16.67%)
injection site reaction ^{† 1}
# participants affected / at risk	1/12 (8.33%)
nail changes ^{† 1}
# participants affected / at risk	4/12 (33.33%)
pruritus ^{† 1}
# participants affected / at risk	1/12 (8.33%)
rash/ desquamation ^{† 1}
# participants affected / at risk	1/12 (8.33%)

†	Events were collected by systematic assessment
1	Term from vocabulary, CTCAE (3.0)

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was terminated before it reached the target accrual number due to slow accrual, leading to small number of subjects analyzed (12 out of the target number of 37).

Results Point of Contact:

Name/Title: Anna Ferrari, MD
Organization: New York University Cancer Institute
phone: 212-731-5389
e-mail: anna.ferrari@nyumc.org

No publications provided

Responsible Party:	Anna Ferrari, MD, NYU Cancer Institute
ClinicalTrials.gov Identifier:	NCT00861471 History of Changes
Other Study ID Numbers:	NYU 04-47 (H12554), Novartis CSTI571BUS200
Study First Received:	March 12, 2009
Results First Received:	April 29, 2011
Last Updated:	August 17, 2011
Health Authority:	United States: Institutional Review Board

To Top