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Metastatic CancerPhase 2NCT00084825

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

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. Giving docetaxel with imatinib mesylate may kill more tumor cells. 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?
No, everyone receives an active treatment
How many people
23 participants
Where
3 sitesUnited States
Study dates
May 2003to Jun 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
  • 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

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

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.

Read the detailed 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.

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

    30 mg/m^2 IV on days 1, 8, 15, and 22 every 42 days

  • Imatinib mesylateDrug

    600 mg orally daily

Study groups in NCT00084825
Study groupRoleWhat they receive
Docetaxel + Imatinib MesylateExperimentalDocetaxel intravenous (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.
Receives: Drug: Docetaxel; Drug: Imatinib mesylate

What is being measured

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

  1. Treatment efficacy

    Measured: 12 weeks after initiation of crossover therapy

Secondary outcomes (2)

  1. 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.

    Measured: From registration to disease progression, up to 32 months

  2. Response rate

    Measured: Up to 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 posted11 Jun 2004 (estimated)
  2. Study startMay 2003
  3. Primary completionJul 2006
  4. Study completionJun 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00084825
Sponsor's protocol ID
CDR0000365625
Other IDs
MDA-ID-030222, MSKCC-03149, ID03-0222
Status last verified
Oct 2012
First submitted
10 Jun 2004
Last updated
26 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 26 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. 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?

Treatment efficacy (time frame: 12 weeks after initiation of crossover therapy). 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 NCT00084825, 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 26 Oct 2012.

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