NCT00084825

Brief Summary

RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving docetaxel with imatinib mesylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel with imatinib mesylate works in treating patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and a placebo on clinical trial MDA-ID-030008.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2003

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

3.2 years

First QC Date

June 10, 2004

Last Update Submit

October 24, 2012

Conditions

Metastatic CancerProstate Cancer

Keywords

adenocarcinoma of the prostaterecurrent prostate cancerstage IV prostate cancerbone metastases

Outcome Measures

Primary Outcomes (1)

  • Treatment efficacy

    12 weeks after initiation of crossover therapy

Secondary Outcomes (2)

  • Time to progression

    From registration to disease progression, up to 32 months

  • Response rate

    Up to 3 years

Study Arms (1)

Docetaxel + Imatinib Mesylate

EXPERIMENTAL

Docetaxel intravenous (IV) over 1 hour on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-42. Courses repeat every 42 days.

Drug: DocetaxelDrug: Imatinib mesylate

Interventions

DocetaxelDRUG

30 mg/m\^2 IV on days 1, 8, 15, and 22 every 42 days

Docetaxel + Imatinib Mesylate
Imatinib mesylateDRUG

600 mg orally daily

Docetaxel + Imatinib Mesylate

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of adenocarcinoma of the prostate * Osseous metastases * Androgen-independent disease * Previously randomized to the docetaxel and placebo arm of protocol MDA-ID-030008 and has been removed from protocol due to disease progression * No more than 6 weeks since final treatment with docetaxel and placebo * No uncontrolled brain metastases or spinal cord compression PATIENT CHARACTERISTICS: Age * Any age Performance status * Eastern Cooperative Oncology Group (ECOG) 0-3 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2 times upper limit of normal * No chronic liver disease Renal * Creatinine clearance ≥ 40 mL/min Cardiovascular * No New York Heart Association class III or IV congestive heart failure * No unstable angina * No uncontrolled severe hypertension * No myocardial infarction within the past 6 months Pulmonary * No oxygen-dependent lung disease Other * No prior dose-limiting toxicity with docetaxel requiring more than 2 dose reductions * No severe hypersensitivity to docetaxel * No prior dose-limiting toxicity with docetaxel requiring 1 dose reduction AND experienced recurrent grade 3 or 4 toxicity at the time of progression on MDA-ID-030008 * No uncontrolled diabetes mellitus * No concurrent severe infection * No overt psychosis, mental disability, or other incompetency that would preclude giving informed consent * No history of non-compliance * HIV negative * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biologic therapy Chemotherapy * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy * No concurrent second-line hormonal therapy Radiotherapy * At least 3 weeks since prior radiotherapy * No recent strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium Surgery * Recovered from prior surgery Other * No other concurrent anticancer agents * No other concurrent investigational agents * No concurrent therapeutic warfarin * Concurrent mini-dose warfarin (1 mg/day) for central venous catheter prophylaxis allowed * No concurrent grapefruit or grapefruit juice

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

  • Mathew P, Thall PF, Johnson MM, et al.: Preliminary results of a randomized placebo-controlled double-blind trial of weekly docetaxel combined with imatinib in men with metastatic androgen-independent prostate cancer (AIPC) and bone metastases (BM). [Abstract] J Clin Oncol 24 (Suppl 18): A-4562, 232s, 2006.

    RESULT

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisProstatic Neoplasms

Interventions

DocetaxelImatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Paul Mathew

    M.D. Anderson Cancer Center

    STUDY CHAIR

  • Christopher Logothetis, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

May 1, 2003

Primary Completion

July 1, 2006

Study Completion

June 1, 2008

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations

US(3)