NCT00080678

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. Combining docetaxel with imatinib mesylate may be effective treatment for androgen-independent prostate cancer and bone metastases. PURPOSE: This randomized phase II trial is studying docetaxel and imatinib mesylate to see how well they work compared to docetaxel alone in treating patients with androgen-independent prostate cancer and bone metastases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 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
11 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

October 12, 2012

Status Verified

October 1, 2012

Enrollment Period

2.3 years

First QC Date

April 7, 2004

Last Update Submit

October 10, 2012

Conditions

Metastatic CancerProstate Cancer

Keywords

adenocarcinoma of the prostaterecurrent prostate cancerstage IV prostate cancerbone metastases

Outcome Measures

Primary Outcomes (1)

  • Time to progression

    Baseline to 3 years, or until disease progression

Secondary Outcomes (2)

  • Response rate

    Up to 3 years

  • Toxic effects

    3 years

Study Arms (2)

Docetaxel + Imatinib Mesylate

EXPERIMENTAL

Docetaxel 30 mg/m\^2 intravenous over 60 minutes on days 1, 8, 15, and 22 in 42-day cycles, with daily oral 600 mg imatinib mesylate.

Drug: DocetaxelDrug: Imatinib Mesylate

Docetaxel + Placebo

PLACEBO COMPARATOR

Docetaxel 30 mg/m\^2 intravenous (IV) over 60 minutes on days 1, 8, 15, and 22 in 42-day cycles, with daily oral placebo.

Drug: Docetaxel

Interventions

DocetaxelDRUG
Also known as: taxotere
Docetaxel + Imatinib MesylateDocetaxel + Placebo
Imatinib MesylateDRUG
Also known as: Imatinib, Gleevec, STI571, NSC-716051
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 confirmed by radiography * Lytic bone lesions considered for biopsy if there is clinical suspicion of histologic conversion to small cell carcinoma * Failed prior hormonal therapy * Progressive disease, as evidenced by one of the following: * 2 consecutive rises in prostate-specific antigen (PSA) of at least 1 ng/mL over 4 weeks * Increase of 25% of the product of bidimensional disease or 30% in maximum diameter * Increase in number of osseous metastases by bone scan * Worsening symptoms attributable to disease progression (e.g., worsening bony pain) * PSA ≥ 1 ng/mL * Castrate serum testosterone ≤ 50 ng/dL * Concurrent luteinizing-hormone releasing-hormone analog required for medically castrated patients * No small cell or sarcomatoid prostate cancers * No uncontrolled CNS metastases PATIENT CHARACTERISTICS: Age * Any age Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤ 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 myocardial infarction within the past 6 months * No evidence of myocardial ischemia on electrocardiogram * No uncontrolled severe hypertension Pulmonary * No oxygen-dependent lung disease Other * HIV negative * No concurrent severe infection * No contraindication to corticosteroids * No uncontrolled diabetes mellitus * No grade 2 or greater peripheral neuropathy * No other malignancy within the past 2 years except nonmelanoma skin cancer * No overt psychosis, mental disability, or incompetency that would preclude giving informed consent * No history of noncompliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * No prior taxanes * No more than 2 prior chemotherapy regimens * At least 30 days since prior chemotherapy and recovered * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * At least 4 weeks since prior flutamide or nilutamide\* * At least 6 weeks since prior bicalutamide\* NOTE: \*Unless there is evidence of interim disease progression Radiotherapy * At least 90 days since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium and recovered * At least 30 days since other prior radiotherapy and recovered Surgery * Fully recovered from prior surgery Other * No concurrent ketoconazole * No concurrent warfarin

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

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
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2004

First Posted

April 8, 2004

Study Start

May 1, 2003

Primary Completion

August 1, 2005

Study Completion

March 1, 2008

Last Updated

October 12, 2012

Record last verified: 2012-10

Locations

US(3)