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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00084825
• Other study ID #: CDR0000365625
• Secondary ID: MDA-ID-030222MSK
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2004
• Last updated: October 24, 2012
• Start date: May 2003
• Est. completion date: June 2008

Study information

• Verified date: October 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2008
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel
30 mg/m^2 IV on days 1, 8, 15, and 22 every 42 days
• Imatinib mesylate
600 mg orally daily

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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). [Abst

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment efficacy		12 weeks after initiation of crossover therapy	No
Secondary	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.	From registration to disease progression, up to 32 months	No
Secondary	Response rate		Up to 3 years	No

External Links

•   UT MD Anderson Cancer Center Official Website