Breast NeoplasmPhase 2NCT00194727
Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer
A Phase 2 study testing Vinorelbine and Capecitabine in people with Breast Neoplasm, run by University of Washington at 1 site in United States.
Trial summary
The primary purpose of the study is to examine the safety and effectiveness of combination therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV breast cancer subjects. The study is designed to assess the safety and effectiveness of this combination therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Vinorelbine and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Mar 2011
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be older than 18 and younger than 85.
- Subject must have metastatic (stage IV) breast cancer.
- Subject must have pathologic confirmation of breast cancer (at least of primary disease). Biopsy confirmation of stage IV disease is desirable but not required. Tissue blocks must be available for review.
- Subject must have measurable or non-measurable disease as defined below:
- Measurable disease includes lesions that can be accurately measured in at least one dimension as greater than 2.0 cm with conventional techniques or as greater than 1.0 cm with spiral CT scan.
- Non-measurable disease includes all other lesions (e.g. lesions less than 2.0 cm by conventional techniques or less than 1.0 cm by spiral CT, bone lesions, pleural effusion, etc.).
- Subject must be willing and able to provide informed consent.
Who cannot join
- Subject must not have significant co-morbid conditions such as clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias), or myocardial infarction within the last 12 months or serious concurrent infection.
- Subject must not have rapidly progressing visceral involvement (e.g. liver, lymphangitic lung).
- Subject must not have evidence of CNS metastases.
- Subject must not have abnormal hematologic values (neutrophils less than 1.5 x 103/uL, platelet count less than 100 x 103/uL).
- Subject must not have impaired renal function (serum creatinine greater than 1.5 x upper normal limit) or estimated creatinine clearance below 30 mL/min by the Cockcroft and Gault equation.
- Subject must not have serum bilirubin greater than 1.5 x upper normal limit.
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- Subject must not have ALT or AST greater than 2.5 x upper normal limit (or greater than 5 x upper normal limit in the case of liver metastases).
- Subject must not have alkaline phosphatase greater than 2.5 x upper normal limit (or greater than 5 x upper normal limit in the case of liver metastases or greater than 10 x upper normal limit in the case of bone disease).
- Subject must not have a lack of physical integrity of the upper gastrointestinal tract, inability to swallow or malabsorption syndrome
- Subject must not have a history of fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 12 months earlier).
- Subject must not have a life expectancy less than 3 months.
- Subject must not have a Karnofsky Performance Status less than 70%.
- Subject must not have a history of another carcinoma within the last five years except non-melanoma skin and treated in-situ cervical cancer.
- Subject must not have a history of unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.
- Subject must not have organ allografts.
- Subject must not be pregnant or lactating woman. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Subject must not be less than four weeks from completion of previous chemotherapy regimen or with related toxicities unresolved prior to the start of study treatment.
- Subject must not be less than four weeks from major surgery or without complete recovery.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington; Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
About this study
Official title: Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer: A Phase II Trial With Molecular Correlates
The primary purpose of the study is to examine the safety and effectiveness of combination therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV breast cancer subjects. The study is designed to assess the safety and effectiveness of this combination therapy. Safety will be assessed by analyzing the types of toxicity, the severity of toxicity and the need for dose modification or delay due to toxicity. Effectiveness will be assessed by analyzing response rates, time to treatment failure, time to progression and overall survival. Our hypothesis is that the regimen will be more effective than standard historic regimens for this type and stage of cancer.
Read the detailed description
Single-agent chemotherapy is rarely curative in advanced breast cancer. Combination regimens are the next logical step in the attempt to improve tumor response rates and prolong survival. Oral capecitabine is a convenient way to deliver drug a 5-fluorouracil analogue. In addition, vinorelbine is a newer vinca alkaloid chemotherapeutic agent with improved efficacy and probably improved toxicity over its predecessors in the treatment of breast cancer. We propose combining these two agents. As these two drugs have non-overlapping toxicities and differing mechanisms of action, we anticipate being able to deliver both drugs in near full dose.
Secondary purposes include assessing whether there is a correlation between intra-tumoral enzyme levels and prognosis.
- Conditions
- Breast Neoplasm
- Being tested
- Vinorelbine, Capecitabine
- Keywords
- 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.
VinorelbineDrug
20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
CapecitabineDrug
825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vinorelbine (20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle) and capecitabine (825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle). Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy. Receives: Drug: Vinorelbine; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best response as determined at the time that the subject completes protocol treatment
Measured: <= 4 years
Secondary outcomes (4)
Time to progression as determined at the time that each subject's disease worsens following treatment
Measured: <= 4 years
Median survival at two and three years following the start of protocol treatment.
Measured: <= 3 years
Correlation between intra-tumoral enzyme levels and prognosis
Measured: <= 4 years
Measure the toxicity of the regimen
Measured: During study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, Pfizer
- Responsible party
- Sponsor
- Investigators
- Georgiana K. Ellis, M.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194727
- Sponsor's protocol ID
- 20912-A
- Other IDs
- 02-1544-A 06
- Status last verified
- Sep 2012
- First submitted
- 13 Sep 2005
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer: A Phase II Trial With Molecular Correlates
- ClinicalTrials.gov ID
- NCT00194727
- Acronym / sponsor ID
- 20912-A
- Conditions
- Breast Neoplasm
- Keywords
- Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, Pfizer
- Study start
- May 2002
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Sep 2005 (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.
The primary purpose of the study is to examine the safety and effectiveness of combination therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV breast cancer subjects. The study is designed to assess the safety and effectiveness of this combination therapy. Safety will be assessed by analyzing the types of toxicity, the severity of toxicity and the need for dose modification or delay due to toxicity. Effectiveness will be assessed by analyzing response rates, time to treatment failure, time to progression and overall survival. Our hypothesis is that the regimen will be more effective than standard historic regimens for this type and stage of cancer.
Detailed description
Single-agent chemotherapy is rarely curative in advanced breast cancer. Combination regimens are the next logical step in the attempt to improve tumor response rates and prolong survival. Oral capecitabine is a convenient way to deliver drug a 5-fluorouracil analogue. In addition, vinorelbine is a newer vinca alkaloid chemotherapeutic agent with improved efficacy and probably improved toxicity over its predecessors in the treatment of breast cancer. We propose combining these two agents. As these two drugs have non-overlapping toxicities and differing mechanisms of action, we anticipate being able to deliver both drugs in near full dose.
Secondary purposes include assessing whether there is a correlation between intra-tumoral enzyme levels and prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vinorelbine, Drug: CapecitabineVinorelbine (20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle) and capecitabine (825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle). Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be older than 18 and younger than 85.
- Subject must have metastatic (stage IV) breast cancer.
- Subject must have pathologic confirmation of breast cancer (at least of primary disease). Biopsy confirmation of stage IV disease is desirable but not required. Tissue blocks must be available for review.
- Subject must have measurable or non-measurable disease as defined below:
- Measurable disease includes lesions that can be accurately measured in at least one dimension as greater than 2.0 cm with conventional techniques or as greater than 1.0 cm with spiral CT scan.
Key exclusion criteria (18 listed)
- Subject must not have significant co-morbid conditions such as clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias), or myocardial infarction within the last 12 months or serious concurrent infection.
- Subject must not have rapidly progressing visceral involvement (e.g. liver, lymphangitic lung).
- Subject must not have evidence of CNS metastases.
- Subject must not have abnormal hematologic values (neutrophils less than 1.5 x 103/uL, platelet count less than 100 x 103/uL).
- Subject must not have impaired renal function (serum creatinine greater than 1.5 x upper normal limit) or estimated creatinine clearance below 30 mL/min by the Cockcroft and Gault equation.
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 |
|---|---|---|
| Vinorelbine20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy. | Drug | 1 |
| Capecitabine825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy. | Drug | 1 |
Primary outcome
Best response as determined at the time that the subject completes protocol treatment
Time frame: <= 4 years
4 secondary outcomes
Time to progression as determined at the time that each subject's disease worsens following treatment
Time frame: <= 4 years
Median survival at two and three years following the start of protocol treatment.
Time frame: <= 3 years
Correlation between intra-tumoral enzyme levels and prognosis
Time frame: <= 4 years
Measure the toxicity of the regimen
Time frame: During study treatment
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 Sep 2012.
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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.
Georgiana K. Ellis, M.D. principal investigator
University of Washington
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 Vinorelbine and Capecitabine in people with Breast Neoplasm, run by University of Washington 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?
The sponsor lists 7 inclusion and 18 exclusion criteria. 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 Sep 2012. 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?
Best response as determined at the time that the subject completes protocol treatment (time frame: <= 4 years). 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 Sep 2012.