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Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008


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

Thank you

Trial Information

Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Treatment efficacy

Outcome Time Frame:

12 weeks after initiation of crossover therapy

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:

CDR0000365625

NCT ID:

NCT00084825

Start Date:

May 2003

Completion Date:

June 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 CenterNew York, New York  10021
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030