Breast CancerPhase 3NCT00008411
Docetaxel in Treating Patients With Metastatic Breast Cancer
A Phase 3 study testing Docetaxel in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 1999to Jan 2007
- Phase
- Phase 3
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic breast cancer
- Bidimensionally measurable disease
- No uncontrolled brain metastases or leptomeningeal disease
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count at least 100,000/mm^3
- Neutrophil count at least 1,000/mm^3
- Hemoglobin at least 8 g/dL
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT/SGPT no greater than 1.5 times ULN (2.5 times ULN provided alkaline phosphatase no greater than ULN)
- Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN provided transaminases no greater than ULN)
Renal:
- Creatinine no greater than 2.0 mg/dL
Neurologic:
- No peripheral neuropathy grade 2 or greater
- Neurologic status must be stable 2 weeks after surgery and/or radiotherapy for brain metastasis
- No psychiatric disorders
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated malignancy
- No other serious condition or illness, including active infection
- No history of hypersensitivity to polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Recovered from prior chemotherapy
- No more than 2 prior chemotherapy regimens (no more than 1 prior regimen for metastatic disease)
- No prior paclitaxel or docetaxel (except in the adjuvant setting)
- At least 12 months since prior adjuvant taxane (paclitaxel or docetaxel)
- Prior anthracycline-based therapy allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 2 weeks since prior radiotherapy and recovered
Surgery:
- At least 2 weeks since prior surgery and recovered
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, 77030-4009
About this study
Official title: Phase III Study Comparing the Use of Docetaxel on a Every Three-Week vs. Weekly Schedule in the Treatment of Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer.
Read the detailed description
OBJECTIVES:
- Compare the objective tumor response rate, duration of response, time to progression, progression-free survival, and overall survival in women with metastatic breast cancer treated with docetaxel administered weekly vs every three weeks.
- Compare the safety and toxicity of these regimens in these patients.
- Evaluate the maintenance of relative dose intensity with each regimen in these patients.
- Correlate pretreatment serum HER2/neu level and response with docetaxel therapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior taxane use (yes vs no), number of prior chemotherapy regimens for metastatic disease (0 vs 1), and participating center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
- Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.
Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks, at 3, 6, 9, and 12 months, and then annually for 4 years.
PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
Every 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days.
DocetaxelDrug
Also called Taxotere
35 mg/m2 IV over 30 minutes on days 1, 8, and 15, for 3 weeks followed by one week of rest repeated every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel Weekly | Experimental | Arm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days. Receives: Drug: Docetaxel |
| Docetaxel Every 3 Weeks | Experimental | Arm II: Docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Tumor Response Rate
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 1999
- Primary completionMar 2006
- Study completionJan 2007
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 Breast 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 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
- Edgardo Rivera, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00008411
- Sponsor's protocol ID
- ID99-242
- Other IDs
- P30CA016672, MDA-ID-99242, AVENTIS-MDA-ID-99242, NCI-1691, CDR0000068408
- Status last verified
- Jul 2012
- First submitted
- 6 Jan 2001
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Rivera E, Mejia JA, Arun BK, Adinin RB, Walters RS, Brewster A, Broglio KR, Yin G, Esmaeli B, Hortobagyi GN, Valero V. Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Cancer. 2008 Apr 1;112(7):1455-61. doi: 10.1002/cncr.23321.
PubMed 18300256
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study Comparing the Use of Docetaxel on a Every Three-Week vs. Weekly Schedule in the Treatment of Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00008411
- Acronym / sponsor ID
- ID99-242
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 1999
- Primary completion
- Mar 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 27 Jan 2003 (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 use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer.
Detailed description
OBJECTIVES:
- Compare the objective tumor response rate, duration of response, time to progression, progression-free survival, and overall survival in women with metastatic breast cancer treated with docetaxel administered weekly vs every three weeks.
- Compare the safety and toxicity of these regimens in these patients.
- Evaluate the maintenance of relative dose intensity with each regimen in these patients.
- Correlate pretreatment serum HER2/neu level and response with docetaxel therapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior taxane use (yes vs no), number of prior chemotherapy regimens for metastatic disease (0 vs 1), and participating center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
- Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.
Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks, at 3, 6, 9, and 12 months, and then annually for 4 years.
PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel Weekly | Experimental | Drug: DocetaxelArm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days. |
| Docetaxel Every 3 Weeks | Experimental | Drug: DocetaxelArm II: Docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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: TaxotereEvery 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days. | Drug | Docetaxel Every 3 Weeks |
| DocetaxelAlso: Taxotere35 mg/m2 IV over 30 minutes on days 1, 8, and 15, for 3 weeks followed by one week of rest repeated every 28 days. | Drug | Docetaxel Weekly |
Primary outcome
Objective Tumor Response Rate
Time frame: Weekly
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 30 Jul 2012.
- Results publication: PubMed 18300256Rivera E, Mejia JA, Arun BK, Adinin RB, Walters RS, Brewster A, Broglio KR, Yin G, Esmaeli B, Hortobagyi GN, Valero V. Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Cancer. 2008 Apr 1;112(7):1455-61. doi: 10.1002/cncr.23321.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Edgardo Rivera, MD study chair
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Objective Tumor Response Rate (time frame: Weekly). 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 NCT00008411, 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 30 Jul 2012.