Breast CancerPhase 2NCT00693719
Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer
A Phase 2 study testing Etoposide and Irinotecan hydrochloride in people with Breast Cancer, run by University of Arizona at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Etoposide and Irinotecan hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of locally advanced or metastatic breast cancer
- Recurrent, refractory or progressive disease after receiving prior anthracycline, taxane, and capecitabine therapy
- Prior anthracycline and taxane therapy may have been as neoadjuvant, or adjuvant therapy if disease progression is documented within a year of completing that agent
- Received prior capecitabine therapy for metastatic or recurrent disease
- Measurable disease
- Bone metastases requires other disease present that can be measured
- No brain metastases, unless documented to be controlled post-completion of local therapy (surgery and/or radiation therapy) for at least 4 weeks
- No meningeal carcinomatosis
- No malignant effusion as the only site of disease recurrence
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Performance status of 0-2
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 40 mL/min
- Hemoglobin ≥ 10 g/dL
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal or hyperbilirubinemia < grade 1 (unless due to Gilbert syndrome with elevated total but normal levels of conjugated bilirubin)
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other non-breast malignancy, except nonmelanoma skin cancer
- No other serious underlying medical condition, that in the opinion of the treating physician, would make study protocol unreasonably hazardous for the patient or would preclude the patient's ability to comply with the study protocol
PRIOR CONCURRENT THERAPY:
- See Disease Characteristic
- Recovered from all prior chemotherapy or radiotherapy to NCI CTC grade ≤ 1
- Unlimited documented prior chemotherapy regimens allowed
- No prior irinotecan hydrochloride or etoposide
- No Hypericum perforatum (St. John's wort) 14 days prior to, during, or 7 days after completion of study therapy
- At least 7 days since prior and no concurrent phenytoin, carbamazepine, phenobarbital, or any other enzyme-inducing anticonvulsant drug (EIACD)
- No concurrent aprepitant
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024
About this study
Official title: A Phase II Study: Irinotecan and Etoposide as Treatment for Refractory, Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as irinotecan and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with etoposide works in treating patients with recurrent, locally advanced, or metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the response rate, as assessed by RECIST criteria, in patients with recurrent locally advanced or metastatic breast cancer treated with irinotecan hydrochloride and etoposide after prior exposure to anthracycline, taxane, and capecitabine therapy.
Secondary
- To determine the median time to progression in these patients.
- To determine the response duration and survival in these patients.
- To measure the type and rate of grade 3 or greater toxicity of this treatment regimen in these patients.
OUTLINE: Patients receive irinotecan hydrochloride IV on days 1 and 15 and oral etoposide on days 1-14. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
After completion of study therapy, patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
- Conditions
- Breast Cancer
- Being tested
- Etoposide, Irinotecan hydrochloride
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV 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.
EtoposideDrug
Also called Vepesid
50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
Also called Irinotecan hydrochloride trihydrate
Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
| Study group | Role | What they receive |
|---|---|---|
| Etoposide and Irinotecan hydrochloride | Experimental | Irinotecan 100 mg/m2 IV days 1 and 15. Etoposide 50 mg PO x14 days followed by 2 weeks off. Receives: Drug: Etoposide; Drug: Irinotecan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time to Progression
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months
Secondary outcomes (1)
Overall Survival
Still alive for a certain period of time after they were diagnosed with or started treatment
Measured: Measured from the start of protocol therapy until the date of death from any cause or will be censored at the date the patient was last known to be alive, assesed up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startAug 2007
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 University of ArizonaThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert B. Livingston, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693719
- Sponsor's protocol ID
- 07-0327-04
- Other IDs
- P30CA016672, UARIZ-BIO07046, UARIZ-143, PFIZER-GA59608L, UARIZ-P18089
- Status last verified
- Aug 2013
- First submitted
- 6 Jun 2008
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Segar JM, Reed D, Stopeck A, Livingston RB, Chalasani P. A Phase II Study of Irinotecan and Etoposide as Treatment for Refractory Metastatic Breast Cancer. Oncologist. 2019 Dec;24(12):1512-e1267. doi: 10.1634/theoncologist.2019-0516. Epub 2019 Aug 5.
PubMed 31383812
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study: Irinotecan and Etoposide as Treatment for Refractory, Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00693719
- Acronym / sponsor ID
- 07-0327-04
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Posted 21 Aug 2013
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 irinotecan and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with etoposide works in treating patients with recurrent, locally advanced, or metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the response rate, as assessed by RECIST criteria, in patients with recurrent locally advanced or metastatic breast cancer treated with irinotecan hydrochloride and etoposide after prior exposure to anthracycline, taxane, and capecitabine therapy.
Secondary
- To determine the median time to progression in these patients.
- To determine the response duration and survival in these patients.
- To measure the type and rate of grade 3 or greater toxicity of this treatment regimen in these patients.
OUTLINE: Patients receive irinotecan hydrochloride IV on days 1 and 15 and oral etoposide on days 1-14. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
After completion of study therapy, patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etoposide and Irinotecan hydrochloride | Experimental | Drug: Etoposide, Drug: Irinotecan hydrochlorideIrinotecan 100 mg/m2 IV days 1 and 15. Etoposide 50 mg PO x14 days followed by 2 weeks off. |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| EtoposideAlso: Vepesid50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle | Drug | Etoposide and Irinotecan hydrochloride |
| Irinotecan hydrochlorideAlso: Irinotecan hydrochloride trihydrateIrinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle | Drug | Etoposide and Irinotecan hydrochloride |
Primary outcome
Median Time to Progression
Time frame: Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
1 secondary outcome
Overall Survival
Time frame: Measured from the start of protocol therapy until the date of death from any cause or will be censored at the date the patient was last known to be alive, assesed up to 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31383812Segar JM, Reed D, Stopeck A, Livingston RB, Chalasani P. A Phase II Study of Irinotecan and Etoposide as Treatment for Refractory Metastatic Breast Cancer. Oncologist. 2019 Dec;24(12):1512-e1267. doi: 10.1634/theoncologist.2019-0516. Epub 2019 Aug 5.
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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.
Robert B. Livingston, MD principal investigator
University of Arizona
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 Etoposide and Irinotecan hydrochloride in people with Breast Cancer, run by University of Arizona 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 20 Nov 2015. 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?
Yes. Results are posted in the registry (first posted 21 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Time to Progression (time frame: Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months). 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 NCT00693719, 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 20 Nov 2015.