Breast CancerPhase 1/2NCT00020332
Docetaxel and Flavopiridol in Treating Patients With Locally Advanced or Metastatic Breast Cancer
A Phase 1/2 study testing alvocidib and docetaxel in people with Breast Cancer, run by National Cancer Institute (NCI) at 1 site 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 I/II trial to study the effectiveness of combination chemotherapy in treating patients who have locally advanced or metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- alvocidib and docetaxel
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Mar 2003
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage III or IV adenocarcinoma of the breast
- Phase I:
- Evaluable disease allowed
- Phase II:
- At least 1 site of measurable disease
- No bone metastasis as only site of disease
- No carcinomatous meningitis or brain metastases
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No active coagulopathy requiring therapeutic anticoagulation
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- No Gilbert's disease
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- Left ventricular ejection fraction at least 50% without clinical signs or symptoms of heart failure
- No uncontrolled hypertension (sustained systolic blood pressure (BP) greater than 180 mm Hg or diastolic BP greater than 100 mm Hg)
- No uncontrolled cardiac arrhythmia
- No myocardial infarction within the past year
- No significant ischemia or valvular heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No medical or psychiatric condition that would increase risk
- No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanomatous skin cancer
- No grade 2 or greater peripheral neuropathy
- No diabetes mellitus with a fasting blood sugar greater than 200 mg/dL
- No active unresolved infection
- No serious concurrent medical illness
- No history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior flavopiridol
- Prior adjuvant chemotherapy for advanced disease allowed if within 6 months of diagnosis of metastatic disease
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or 8 weeks for UCN-01) and recovered
- Phase I:
- Any number of prior chemotherapy regimens for metastatic carcinoma of the breast allowed
- Phase II:
- No more than 2 prior chemotherapy regimens for metastatic carcinoma of the breast
Endocrine therapy:
- Prior hormonal therapy in the metastatic or adjuvant setting allowed
- At least 2 weeks since prior hormonal therapy and no evidence of disease improvement by radiography after therapy
- Concurrent corticosteroids allowed if for study premedication or hypersensitivity reactions/adverse events
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent antineoplastic therapies
- No other concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: A Phase I/II Trial of Docetaxel Followed by Infusional Flavopiridol Over 72 Hours in Patients With Previously Treated Locally Advanced or 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 I/II trial to study the effectiveness of combination chemotherapy in treating patients who have locally advanced or metastatic breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of docetaxel and flavopiridol in patients with previously treated locally advanced or metastatic breast cancer.
- Determine the dose-limiting toxicity, toxicity profile, and pharmacokinetics of this regimen in these patients.
- Determine the activity of this regimen in these patients.
- Determine the objective response rate in patients treated with this regimen.
- Determine immune dysfunction produced by this regimen as measured by lymphocyte subpopulations, including T-cell activation/memory subsets and natural killer cell/lymphokine-activated killer cell functional subsets in these patients.
- Determine the ability of positron emission tomography scanning to predict response in patients treated with this regimen.
- Determine the response duration, time to treatment failure, and overall survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine whether this regimen is associated with the development of a prothrombotic state in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel IV over 1 hour on day 1 followed by flavopiridol IV over 1 hour or IV continuously on days 2-4. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Sequential dose escalation of docetaxel is preceded or followed by sequential dose escalation of flavopiridol. Cohorts of 3-6 patients receive escalating doses of docetaxel preceded or followed by escalating doses of flavopiridol until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 22 additional patients are accrued to receive flavopiridol and docetaxel at the recommended phase II dose.
Quality of life is assessed at baseline, every 3 courses during study, and then at completion of study.
PROJECTED ACCRUAL: A total of 49 patients (27 for phase I and 22 for phase II) will be accrued for this study within 2 years.
- Conditions
- Breast Cancer
- Being tested
- alvocidib, docetaxel
- Keywords
- stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alvocidibDrug
docetaxelDrug
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 startOct 2000
- Study completionMar 2003
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 National Cancer Institute (NCI)The 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 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Antoinette R. Tan, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00020332
- Sponsor's protocol ID
- CDR0000068292
- Other IDs
- NCI-00-C-0212, NCI-952
- Status last verified
- Jul 2002
- First submitted
- 11 Jul 2001
- Last updated
- 17 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Docetaxel Followed by Infusional Flavopiridol Over 72 Hours in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00020332
- Acronym / sponsor ID
- CDR0000068292
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer, male breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2000
- Study completion
- Mar 2003 (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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients who have locally advanced or metastatic breast cancer.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of docetaxel and flavopiridol in patients with previously treated locally advanced or metastatic breast cancer.
- Determine the dose-limiting toxicity, toxicity profile, and pharmacokinetics of this regimen in these patients.
- Determine the activity of this regimen in these patients.
- Determine the objective response rate in patients treated with this regimen.
- Determine immune dysfunction produced by this regimen as measured by lymphocyte subpopulations, including T-cell activation/memory subsets and natural killer cell/lymphokine-activated killer cell functional subsets in these patients.
- Determine the ability of positron emission tomography scanning to predict response in patients treated with this regimen.
- Determine the response duration, time to treatment failure, and overall survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine whether this regimen is associated with the development of a prothrombotic state in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel IV over 1 hour on day 1 followed by flavopiridol IV over 1 hour or IV continuously on days 2-4. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Sequential dose escalation of docetaxel is preceded or followed by sequential dose escalation of flavopiridol. Cohorts of 3-6 patients receive escalating doses of docetaxel preceded or followed by escalating doses of flavopiridol until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 22 additional patients are accrued to receive flavopiridol and docetaxel at the recommended phase II dose.
Quality of life is assessed at baseline, every 3 courses during study, and then at completion of study.
PROJECTED ACCRUAL: A total of 49 patients (27 for phase I and 22 for phase II) will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| alvocidib | Drug | – |
| docetaxel | Drug | – |
Primary outcome
Not reported in the source record.
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 17 Jun 2013.
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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.
Antoinette R. Tan, MD study chair
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing alvocidib and docetaxel in people with Breast Cancer, run by National Cancer Institute (NCI) at 1 site 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 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 17 Jun 2013.