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

NCT00861471 | Terminated Phase 1 Results DMC

• 2 other identifiers: NYU 04-47 (H12554)Novartis CSTI571BUS200
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

This trial is designed to determine the proper doses of Docetaxel and Imatinib mesylate to be used to treat hormone refractory prostate cancer and to evaluate the safety and efficacy of the treatment.

Conditions

Prostate Cancer; Prostatic Neoplasms

Keywords

hormone refractory prostate cancer; tyrosine kinase inhibitor; Gleevec; PSA; prostate specific antigen; growth factor receptor inhibitor; androgen independent

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Prostate Specific Antigen (PSA) Response

  PSA response is defined as a greater than or equal to a 50% decrease in PSA from the baseline without clinical or radiologic evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST). PSA concentration was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.

  up to 9 months

Secondary Outcomes (4)

• Percentage of Participants With Greater or Equal to 80% PSA Reduction From Baseline Without Clinical or Radiologic Evidence of Progression

  up to 9 months

• Percentage of Participants With Measurable Disease Response

  up to 2 years

• Time to PSA Progression

  up to 2 years

• Median Overall Survival Time

  up to 4 years

Study Arms (1)

Docetaxel +Gleevec

EXPERIMENTAL

Drug: Docetaxel; Drug: Imatinib Mesylate

Interventions

Docetaxel DRUG

One treatment cycle is defined as 21 days. Docetaxel: 70 mg/m\^2 (60 mg/m\^2 was tested in Phase I as well), Intravenous, every 21 days.

Also known as: Taxotere

Docetaxel +Gleevec

Imatinib Mesylate DRUG

One treatment cycle is defined as 21 days. Imatinib Mesylate: 24-36 hours after Docetaxel, 600 mg (400 mg was tested in Phase I as well), orally, daily x 14 days.

Also known as: Gleevec

Docetaxel +Gleevec

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years of age.
• Histologically documented diagnosis of adenocarcinoma of prostate gland
• Patients must have hormone refractory prostate cancer having progressed after at least two prior hormonal manipulations with documented castrate levels of testosterone (\<50 ng/dl). PSA ≥ 5 ng/ml
• Patients must have hormone-refractory prostate carcinoma as evidenced by PSA progression, with or without evidence of measurable disease, or evaluable disease by a positive bone scan. PSA progression is defined as \> 25% increase in 2 consecutive tests in which the first increase in PSA should occur a minimum of 1 week from the reference value and this increase in PSA should be confirmed and ≥ 5 ng/ml
• Eligible patients will have been treated with at least two prior hormonal manipulations including androgen deprivation and may have received one prior chemotherapy regimen.
• Any chemotherapy, major surgery, or irradiation must have been completed at least 3 weeks prior to starting study drugs. Patient must have recovered from clinically significant toxicities incurred as a result of previous therapy except nail dystrophy, alopecia, grade 1 peripheral neuropathy, or radiation therapy induced affects (i.e., impotence or incontinence)
• No recent prior flutamide (Eulexin) use within the past 4 weeks, prior bicalutamide (Casodex) use within the past 6 weeks, or prior nilutamide (Nilandron) use within the past 6 weeks.
• Performance status 0,1, 2 (Eastern Cooperative Oncology Group performance status scale)
• Adequate end organ function, defined as the following:
• total bilirubin \< 1.5 x upper limit of Normal (ULN)
• Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) \< 2.5 x ULN
• creatinine \< 1.5 x ULN
• Absolute Neutrophil count (ANC) \> 1.5 x 10\^9/L
• platelets \> 100 x 10\^9/L
• Written, voluntary informed consent.

You may not qualify if:

• Patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
• Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
• Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
• Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
• Patient with untreated brain metastasis or cord compression. However, patients with treated spinal cord compression or central nervous system (CNS) metastases that have been stable are eligible.
• Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
• Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
• Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing.
• Patient previously received radiotherapy to at least 25 % of the bone marrow
• Patient had a major surgery within 2 weeks prior to study entry.
• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
• If the patient is taking steroids for prostate cancer, then the patient is ineligible for this study. If the patient is taking steroids for conditions other than prostate cancer, the patient is eligible provided that the reasons for use and dosage are documented. The investigator is urged to discuss this issue with the Study Principal Investigator for any clarification.
• No therapeutic anticoagulation with warfarin (e.g. Coumadin® or Coumadine®) will be permitted in patients participating in this study.

Sponsors & Collaborators

• NYU Langone Health: lead
• Novartis: collaborator

Study Sites (3)

Bellevue Hospital

New York, New York, 10016, United States

Location

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

NYU Tisch Hospital

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

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

• Title: Anna Ferrari, MD
• Organization: New York University Cancer Institute

anna.ferrari@nyumc.org

212-731-5389

Study Officials

• Anna Ferrari, MD

  New York University Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: May 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 30, 2016
• Results First Posted: June 29, 2011

Record last verified: 2016-05

Locations

US (3)