Breast CancerPhase 2NCT00015886
Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
A Phase 2 study testing docetaxel and fluorouracil in people with Breast Cancer, run by Wake Forest University Health Sciences at 6 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or… Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- docetaxel and fluorouracil
- How many people
- 25 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 1997to Jul 2009
- 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 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Metastatic or unresectable local disease
- Measurable or evaluable disease
- No ascites or pleural effusion as only metastatic site
- No brain or leptomeningeal metastases
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Granulocyte count greater than 1,500/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Bilirubin normal
- SGOT/SGPT less than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase less than 2.5 times ULN
Renal:
- Creatinine no greater than 2 times ULN
Cardiovascular:
- Adequate cardiac function
- No history of significant atherosclerotic coronary disease (e.g., uncontrolled angina)
- No history of significant cardiac arrhythmia
Other:
- No serious medical or psychiatric illness that would preclude study
- No active uncontrolled bacterial, viral, or fungal infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior high-dose chemotherapy and autologous transplantation
Chemotherapy:
- At least 3 weeks since prior chemotherapy and recovered
- No more than 2 prior chemotherapy regimens for metastatic breast cancer (in addition to adjuvant therapy)
- No prior docetaxel
- No prior high-dose chemotherapy and autologous transplantation
- Prior paclitaxel allowed
Endocrine therapy:
- No concurrent hormonal therapy, except as contraception
Radiotherapy:
- At least 3 weeks since prior radiotherapy and recovered
- Concurrent radiotherapy for relief of localized pain or obstruction allowed
Surgery:
- At least 2 weeks since prior major surgery and recovered
Other:
- No other concurrent cytotoxic agents
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Massey Cancer Center
Richmond, Virginia, 23298-0037
Palmetto Hematology/Oncology Associates
Spartanburg, South Carolina, 29303
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
About this study
Official title: Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery.
Read the detailed description
OBJECTIVES:
- Determine the response rate in women with locally unresectable or metastatic breast cancer treated with docetaxel, leucovorin calcium, and fluorouracil as second or third-line chemotherapy.
- Evaluate the toxic effects of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1 and leucovorin calcium IV over 1 hour followed by fluorouracil IV over 5 minutes on days 1-3. Treatment repeats every 4 weeks for 2-8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 44 months.
- Conditions
- Breast Cancer
- Being tested
- docetaxel, fluorouracil
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage IIIB 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
75 milligrams per meter squared intraveneously
fluorouracilDrug
350 milligrams intraveneously
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil
Measured: 28 weeks
Secondary outcomes (1)
To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2003 (estimated)
- Study startJan 1997
- Primary completionMay 2002
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gretchen Kimmick, MD, MS, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015886
- Sponsor's protocol ID
- CDR0000068567
- Other IDs
- CCCWFU-74896, NCI-3137
- Status last verified
- Aug 2018
- First submitted
- 6 May 2001
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00015886
- Acronym / sponsor ID
- CDR0000068567
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 1997
- Primary completion
- May 2002 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Oct 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery.
Detailed description
OBJECTIVES:
- Determine the response rate in women with locally unresectable or metastatic breast cancer treated with docetaxel, leucovorin calcium, and fluorouracil as second or third-line chemotherapy.
- Evaluate the toxic effects of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1 and leucovorin calcium IV over 1 hour followed by fluorouracil IV over 5 minutes on days 1-3. Treatment repeats every 4 weeks for 2-8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 44 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| docetaxel75 milligrams per meter squared intraveneously | Drug | – |
| fluorouracil350 milligrams intraveneously | Drug | – |
Primary outcome
To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil
Time frame: 28 weeks
1 secondary outcome
To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil
Time frame: 28 weeks
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 13 Aug 2018.
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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.
Gretchen Kimmick, MD, MS study chair
Wake Forest University Health Sciences
6 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 fluorouracil in people with Breast Cancer, run by Wake Forest University Health Sciences at 6 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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2018.