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Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases

Primary Purpose

Metastatic Cancer, Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Imatinib Mesylate
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, bone metastases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • M.D. Anderson Cancer Center at University of Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Docetaxel + Imatinib Mesylate

Docetaxel + Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to progression

Secondary Outcome Measures

Response rate
Toxic effects

Full Information

First Posted
April 7, 2004
Last Updated
October 10, 2012
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00080678
Brief Title
Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases
Official Title
Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Compare time to progression in patients with androgen-independent prostate cancer and bone metastases treated with docetaxel with vs without imatinib mesylate. Secondary Compare the response rates in patients treated with these regimens. Compare the toxic effects of these regimens in these patients. Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to hemoglobin (< 11g/dL vs ≥ 11 g/dL), alkaline phosphatase (normal vs elevated), number of prior regimens (0 vs 1 or 2), and ECOG performance score (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive docetaxel IV on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-43. Arm II: Patients receive docetaxel as in arm I and oral placebo once daily on days 1-43. In both arms, courses repeat every 43 days in the absence of disease progression or unacceptable toxicity. Patients who progress on arm II may cross over to arm I. PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, bone metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel + Imatinib Mesylate
Arm Type
Experimental
Arm Description
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.
Arm Title
Docetaxel + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
taxotere
Intervention Type
Drug
Intervention Name(s)
Imatinib Mesylate
Other Intervention Name(s)
Imatinib, Gleevec, STI571, NSC-716051
Primary Outcome Measure Information:
Title
Time to progression
Time Frame
Baseline to 3 years, or until disease progression
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
Up to 3 years
Title
Toxic effects
Time Frame
3 years

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Mathew
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christopher Logothetis, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result

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Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases

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