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Metastatic CancerPhase 2NCT00080678

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

A Phase 2 study testing Docetaxel and Imatinib Mesylate in people with Metastatic Cancer and Prostate Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Metastatic Cancer, Prostate Cancer
What is being tested?
Docetaxel and Imatinib Mesylate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
116 participants
Where
3 sitesUnited States
Study dates
May 2003to Mar 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

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

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. Combining docetaxel with imatinib mesylate may be effective treatment for androgen-independent prostate cancer and bone metastases.

PURPOSE: This randomized phase II trial is studying docetaxel and imatinib mesylate to see how well they work compared to docetaxel alone in treating patients with androgen-independent prostate cancer and bone metastases.

Read the detailed description

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.

Being tested
Docetaxel, Imatinib Mesylate
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, bone metastases
Medical subject headings
Neoplasm Metastasis, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called taxotere

  • Imatinib MesylateDrug

    Also called Imatinib, Gleevec, STI571, NSC-716051

Study groups in NCT00080678
Study groupRoleWhat they receive
Docetaxel + Imatinib MesylateExperimentalDocetaxel 30 mg/m^2 intravenous over 60 minutes on days 1, 8, 15, and 22 in 42-day cycles, with daily oral 600 mg imatinib mesylate.
Receives: Drug: Docetaxel; Drug: Imatinib Mesylate
Docetaxel + PlaceboPlacebo comparatorDocetaxel 30 mg/m^2 intravenous (IV) over 60 minutes on days 1, 8, 15, and 22 in 42-day cycles, with daily oral placebo.
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to progression

    Measured: Baseline to 3 years, or until disease progression

Secondary outcomes (2)
  1. Response rate

    Measured: Up to 3 years

  2. Toxic effects

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2004 (estimated)
  2. Study startMay 2003
  3. Primary completionAug 2005
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00080678
Sponsor's protocol ID
CDR0000354505
Other IDs
MDA-ID-030008, NOVARTIS-MDA-ID-030008, MSKCC-03132, DFCI-03187
Status last verified
Oct 2012
First submitted
7 Apr 2004
Last updated
12 Oct 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel and Imatinib Mesylate in people with Metastatic Cancer and Prostate Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to progression (time frame: Baseline to 3 years, or until disease progression). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00080678, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.

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