A Study of Imatinib and Docetaxel in Prostate Cancer

NCT00251225 | Completed Phase 2 Results DMC

• 1 other identifier: 05-019
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effectiveness of two drugs, docetaxel and Gleevec®(also called imatinib), in prostate cancer that no longer responds to hormone therapy. The investigators are interested in finding out if the combination of these two drugs is more effective than docetaxel alone in the treatment of prostate cancer.

Conditions

Prostate Cancer

Keywords

prostate

Outcome Measures

Primary Outcomes (1)

• Overall Time To Progression (TTP)

  TTP is the amount of time from date of registration to date of first documentation of progression or symptomatic deterioration. For progression, one or more of the following must occur: (1) 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. (2) Increase in PSA by at least 25% from baseline in patients whose PSA did not decrease, and of 50% from nadir in patients whose PSA decreased with a confirmation 3 weeks later. (3) Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). (4) Appearance of any new lesion/site. (5) Death due to disease without prior documentation of progression and without symptomatic deterioration, which is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

  Up to 24 months

Secondary Outcomes (2)

• Prostate-Specific Antigen (PSA) Response Rate

  Up to 12 months

• Overall Survival (OS)

  Up to 60 months

Study Arms (1)

Hormone Refractory Prostate Cancer

EXPERIMENTAL

Gleevec + Docetaxel: Daily Oral Gleevec in Combination with Every-Three-Week Intravenous Docetaxel

Drug: Gleevec; Drug: Docetaxel

Interventions

Gleevec DRUG

Imatinib-400mg po qd for 10 days to commence on day 3. On day 0, Docetaxel 60mg/m\^2 administered IV

Also known as: Imatinib, Imatinib Mesylate, ST1571

Hormone Refractory Prostate Cancer

Docetaxel DRUG

60 mg/m\^2 administered IV on day 0

Also known as: Taxotere

Hormone Refractory Prostate Cancer

Eligibility Criteria

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

You may qualify if:

• Must have a histologic diagnosis of adenocarcinoma of the prostate Stage D2 that is unresponsive or refractory to hormone therapy. Must have metastatic prostate cancer with a rising PSA, and deemed to be hormone refractory.
• All subjects must have pre-study PSA within 28 days prior to registration
• Subjects who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within 28 days prior to registration. Subjects must have non-measurable disease assessed within 28 days (for PSA level) or 42 days (for imaging studies) prior to registration.
• Subjects with bone metastases, as documented by X-ray, bone scan, MRI, or biopsy.
• All subjects must have had a CT scan of the abdomen and pelvis within 28 days prior to registration.
• Subjects must have been surgically or medically castrated. If the method of castration was LHRH (Luteinizing Hormone-Releasing Hormone) agonists, then the subject must be willing to continue the use of LHRH agonists.
• If the subject has been treated with non-steroidal anti-androgens or other hormonal treatment these agents must have been stopped at least 28 days prior to enrollment for flutamide or ketoconazole, and at least 42 days prior to enrollment for bicalutamide or nilutamide; and the subjects must have demonstrated progression of disease since the agents were suspended.
• Prior radiation therapy is allowed. At least 21 days must have elapsed since the completion of radiation therapy, and the subject must have recovered from the side effects of the radiation
• \. Due to the unknown side effects of imatinib, men of reproductive potential must agree to use an effective contraceptive method.
• Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have significant active concurrent other medical illness precluding protocol treatment.
• ECOG performance status of 0-1
• ANC ≥ 1,500/mL and a platelet count of ³ 100,000/mL. These tests must be obtained within 7 days prior to registration.
• Serum bilirubin ≤ 1.3, SGOT and SGPT ≤ 2 x institutional upper limit of normal, and a serum creatinine ≤ 1.8 mg/dl. These tests must be obtained within 7 days prior to registration. Testosterone level may be done 28 days prior to study entry. Testosterone level should be below 50 ng/dL.

You may not qualify if:

• No prior chemotherapy for hormone-refractory disease is allowed. At least three weeks must have elapsed since the completion of any non-cytotoxic investigational therapy, and the patient must have recovered from the side effects of the therapy.
• No other cytotoxics, biological response modifiers, radiation therapy, corticosteroid or hormonal concomitant therapy (other than continuing LHRH treatment) may be given during protocol treatment. Bisphosphonates may be given during protocol treatment. No unconventional therapy may be given during protocol treatment.
• Subjects must NOT have Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
• Subjects with known chronic liver disease are NOT eligible
• Must NOT have a known diagnosis of human immunodeficiency virus (HIV) infection.
• Subjects must NOT have known brain metastases.
• No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of any site, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

Sponsors & Collaborators

• Leonard Appleman: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Imatinib Mesylate; Docetaxel

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)

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

Results Point of Contact

• Title: Leonard J. Appleman, MD, PhD
• Organization: University of Pittsburgh Cancer Institute

applemanlj@upmc.edu

412-648-6507

Study Officials

• Leonard J Appleman, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 8, 2005
• First Posted: November 9, 2005
• Study Start: August 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2014
• Last Updated: August 9, 2017
• Results First Posted: August 9, 2017

Record last verified: 2017-07

Locations

US (1)