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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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.
- Conditions
- Metastatic Cancer, Prostate Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Docetaxel + Imatinib Mesylate | Experimental | Docetaxel 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 + Placebo | Placebo comparator | Docetaxel 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.
Time to progression
Measured: Baseline to 3 years, or until disease progression
Secondary outcomes (2)
Response rate
Measured: Up to 3 years
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.
- First posted8 Apr 2004 (estimated)
- Study startMay 2003
- Primary completionAug 2005
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Paul Mathew, Study chair, M.D. Anderson Cancer CenterChristopher Logothetis, MD, Study chair, M.D. Anderson Cancer Center
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00080678
- Acronym / sponsor ID
- CDR0000354505
- Conditions
- Metastatic Cancer, Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, bone metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 8 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel + Imatinib Mesylate | Experimental | Drug: Docetaxel, Drug: Imatinib MesylateDocetaxel 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. |
| Docetaxel + Placebo | Placebo comparator | Drug: DocetaxelDocetaxel 30 mg/m^2 intravenous (IV) over 60 minutes on days 1, 8, 15, and 22 in 42-day cycles, with daily oral placebo. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: taxotere | Drug | Docetaxel + Imatinib Mesylate, Docetaxel + Placebo |
| Imatinib MesylateAlso: Imatinib, Gleevec, STI571, NSC-716051 | Drug | Docetaxel + Imatinib Mesylate |
Primary outcome
Time to progression
Time frame: Baseline to 3 years, or until disease progression
2 secondary outcomes
Response rate
Time frame: Up to 3 years
Toxic effects
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
- Results publicationMathew 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Mathew study chair
M.D. Anderson Cancer Center
Christopher Logothetis, MD study chair
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
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.