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Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases


Phase 2
N/A
N/A
Not Enrolling
Male
Metastatic Cancer, Prostate Cancer

Thank you

Trial Information

Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

Baseline to 3 years, or until disease progression

Safety Issue:

No

Principal Investigator

Paul Mathew

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000354505

NCT ID:

NCT00080678

Start Date:

May 2003

Completion Date:

March 2008

Related Keywords:

  • Metastatic Cancer
  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • bone metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030