search
Back to results

Docetaxel and Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases That Progressed on the Docetaxel and Placebo Group of MDA-ID-030008

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 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

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 Type

Experimental

Arm Label

Docetaxel + Imatinib Mesylate

Arm Description

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.

Outcomes

Primary Outcome Measures

Treatment efficacy

Secondary Outcome Measures

Time to progression
Time of progression was defined as the time of appearance of symptoms attributable to disease progression, the first demonstrated clinical sign or radiological evidence of disease progression, or the time of first of consecutive prostate-specific antigen (PSA) increments that achieved 25% increase over baseline or nadir (or death during the study), whichever was earliest.
Response rate

Full Information

First Posted
June 10, 2004
Last Updated
October 24, 2012
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00084825
Brief Title
Docetaxel and Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases That Progressed on the Docetaxel and Placebo Group of MDA-ID-030008
Official Title
Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
June 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. 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.
Detailed Description
OBJECTIVES: Primary Provide treatment with docetaxel and imatinib mesylate for patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and placebo on MDA-ID-030008. Secondary Determine the response rate and time to progression in these patients after crossover from docetaxel and placebo to docetaxel and imatinib mesylate. Compare the modulation of the platelet-derived growth factor receptor pathway by docetaxel and imatinib mesylate vs docetaxel and placebo in the same patient. Determine the quality of life of patients treated with this crossover regimen. OUTLINE: This is an open-label, crossover, multicenter, extension study. Patients who progressed on the placebo and docetaxel arm of MDA-ID-030008 crossover to receive docetaxel and imatinib mesylate. Patients receive docetaxel 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 in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each therapy course, and at the completion of therapy. Patients are followed for 30 days. PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 9 months.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel + Imatinib Mesylate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
30 mg/m^2 IV on days 1, 8, 15, and 22 every 42 days
Intervention Type
Drug
Intervention Name(s)
Imatinib mesylate
Intervention Description
600 mg orally daily
Primary Outcome Measure Information:
Title
Treatment efficacy
Time Frame
12 weeks after initiation of crossover therapy
Secondary Outcome Measure Information:
Title
Time to progression
Description
Time of progression was defined as the time of appearance of symptoms attributable to disease progression, the first demonstrated clinical sign or radiological evidence of disease progression, or the time of first of consecutive prostate-specific antigen (PSA) increments that achieved 25% increase over baseline or nadir (or death during the study), whichever was earliest.
Time Frame
From registration to disease progression, up to 32 months
Title
Response rate
Time Frame
Up to 3 years

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center Official Website

Learn more about this trial

Docetaxel and Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases That Progressed on the Docetaxel and Placebo Group of MDA-ID-030008

We'll reach out to this number within 24 hrs