Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Any age NCI, Pharmaceutical / Industry MDA-ID-030008 NOVARTIS-MDA-ID-030008, MSKCC-03132, DFCI-03187, NCT00080678

Special Category: SPORE trial

Objectives

Primary

1. Compare time to progression in patients with androgen-independent prostate cancer and bone metastases treated with docetaxel with vs without imatinib mesylate.

Secondary

1. Compare the response rates in patients treated with these regimens.
2. Compare the toxic effects of these regimens in these patients.
3. Compare quality of life of patients treated with these regimens.

Entry 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

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

Patient Characteristics:

Age

• Any age

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin ≤ 1.5 mg/dL
• AST and 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

Expected Enrollment

A total of 152 patients (76 per treatment arm) will be accrued for this study.

Outcomes

Time to progression

Response rate
Toxic effects
Quality of life

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.

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Paul Mathew, Protocol chair		Ph: 713-792-2830; 800-392-1611
Christopher Logothetis, MD, Protocol co-chair		Ph: 713-563-7210; 800-392-1611

Registry Information
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
Trial Start Date		2003-05-01
Registered in ClinicalTrials.gov		NCT00080678
Date Submitted to PDQ		2003-10-24
Information Last Verified		2006-09-01
NCI Grant/Contract Number		CA16672, CA90270, CA092629

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