Breast CancerPhase 2NCT00059943
Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer
A Phase 2 study testing docetaxel in people with Breast Cancer and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with metastatic breast, lung, or prostate cancer. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Prostate Cancer
- What is being tested?
- docetaxel
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Sep 2005
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Histologically proven metastatic breast, lung, or prostate cancer
- Measurable disease
- No untreated CNS metastases
- No symptomatic CNS metastases requiring escalating doses of corticosteroids
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 65 and over
Sex
- Not specified
Menopausal status
- Not specified
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Hemoglobin at least 8.0 g/dL
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin normal
- SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) with alkaline phosphatase no greater than ULN OR
- Alkaline phosphatase no greater than 4 times ULN with SGOT and SGPT no greater than ULN
Renal
- Not specified
Cardiovascular
- No history of cardiac arrhythmia
- No congestive heart failure
- No myocardial infarction within the past 6 months
Other
- No prior severe hypersensitivity reaction to docetaxel or other drugs containing polysorbate 80
- No allergy to macrolide antibiotics
- No grade 2 or greater peripheral neuropathy
- No concurrent serious or uncontrolled infection
- Able to read, write, and converse in English
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Recovered from prior chemotherapy
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- Recovered from prior radiotherapy
Surgery
- Not specified
Other
- No concurrent CYP3A4-inducing or inhibiting medications or herbal remedies
- No concurrent grapefruit juice
- No concurrent ethanol
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with metastatic breast, lung, or prostate cancer.
Read the detailed description
OBJECTIVES:
- Determine the pharmacokinetics of docetaxel in older patients with metastatic breast, lung, or prostate cancer.
- Determine the response of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Determine the short-term changes in functional status, in terms of activities of daily living, independent activities of daily living, and Karnofsky performance status, in patients treated with this drug.
- Correlate the number of comorbid conditions at baseline with declines in functional status in patients treated with this drug.
OUTLINE: Patients receive docetaxel IV over 30 minutes once weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.
- Conditions
- Breast Cancer, Lung Cancer, Prostate Cancer
- Being tested
- docetaxel
- Keywords
- stage IV breast cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of docetaxel
Secondary outcomes (5)
Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test
Response
Toxicity
Correlation between toxicity and functional status decline
Relationship between comorbid conditions at baseline and declines in functional status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startSep 2002
- Primary completionSep 2005
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 Memorial Sloan Kettering 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Arti Hurria, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059943
- Sponsor's protocol ID
- 01-136
- Other IDs
- MSKCC-01136
- Status last verified
- Jan 2013
- First submitted
- 6 May 2003
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer
- ClinicalTrials.gov ID
- NCT00059943
- Acronym / sponsor ID
- 01-136
- Conditions
- Breast Cancer, Lung Cancer, Prostate Cancer
- Keywords
- stage IV breast cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2002
- Primary completion
- Sep 2005 (actual)
- First posted
- 7 May 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, such as docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with metastatic breast, lung, or prostate cancer.
Detailed description
OBJECTIVES:
- Determine the pharmacokinetics of docetaxel in older patients with metastatic breast, lung, or prostate cancer.
- Determine the response of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Determine the short-term changes in functional status, in terms of activities of daily living, independent activities of daily living, and Karnofsky performance status, in patients treated with this drug.
- Correlate the number of comorbid conditions at baseline with declines in functional status in patients treated with this drug.
OUTLINE: Patients receive docetaxel IV over 30 minutes once weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| docetaxel | Drug | – |
Primary outcome
Pharmacokinetics of docetaxel
5 secondary outcomes
Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test
Response
Toxicity
Correlation between toxicity and functional status decline
Relationship between comorbid conditions at baseline and declines in functional status
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 16 Jan 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.
Arti Hurria, MD study chair
Memorial Sloan Kettering Cancer Center
1 site 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 in people with Breast Cancer and Lung Cancer, run by Memorial Sloan Kettering Cancer Center 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 16 Jan 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 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?
Pharmacokinetics of docetaxel. 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 16 Jan 2013.