Male Breast CancerNCT00343863
Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer
A study testing palonosetron hydrochloride, cyclophosphamide and dexamethasone in people with Male Breast Cancer and Nausea and Vomiting, run by University of Washington at 1 site in United States.
Trial summary
RATIONALE: Antiemetic drugs, such as dexamethasone, ondansetron hydrochloride, and palonosetron hydrochloride, may help lessen or prevent nausea and vomiting caused by chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Male Breast Cancer, Nausea and Vomiting, Stage I Breast Cancer
- What is being tested?
- palonosetron hydrochloride, cyclophosphamide and dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histologically confirmed diagnosis of primary breast carcinoma
- Patient must be naive to chemotherapy at the time of enrollment
- Patients must have prescribed weekly intravenous adriamycin (doxorubicin) and daily oral cyclophosphamide treatment for early breast cancer
- The patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- Patients must have a Karnofsky index of greater than or equal to 50%
- Known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator
Who cannot join
- Receipt of investigational drug within 30 days before study entry
- Received any drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent (with the exception of administration of the palonosetron/dexamethasone infusion solution), including the following: 5-HT3 receptor antagonists; dopamine receptor antagonists (metoclopramide); phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide (diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of Taxanes); all benzodiazepines; haloperidol, droperidol, tetrahydrocannabinol, or nabilone; any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone) (topical or inhaled preparations are allowed)
- Any vomiting, retching or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea in the 24 hours preceding chemotherapy
- Ongoing vomiting from any organic etiology
- Need to receive systemic corticosteroids, except: a) when defined as part of the chemotherapy regimen as a preventative measure for chemotherapy toxicities; b) topical or inhaled preparations; and/or c) when used as rescue medication during the study
- Known contraindication to 5-HT3 receptor antagonists (including palonosetron) or dexamethasone
- Need to receive radiotherapy during the study
- Inability to understand or cooperate with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Efficacy of Palonosetron in the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting Following Dose Dense Adriamycin-Cyclophosphamide Chemotherapy in Early Stage Breast Cancer Patients
RATIONALE: Antiemetic drugs, such as dexamethasone, ondansetron hydrochloride, and palonosetron hydrochloride, may help lessen or prevent nausea and vomiting caused by chemotherapy.
PURPOSE: This clinical trial studies how well giving dexamethasone together with ondansetron hydrochloride or palonosetron hydrochloride works in preventing nausea and vomiting in patients receiving doxorubicin hydrochloride and cyclophosphamide for early stage breast cancer
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the proportion of patients achieving a complete response (CR), defined as no emesis and no rescue medications in the 0-24 hour time period following weekly intravenous doxorubicin.
SECONDARY OBJECTIVES:
- To determine the proportion of patients achieving a complete response (CR), defined as no emesis and no rescue medications in the 24-120 hour time period following weekly intravenous doxorubicin.
II. To determine the proportion of patients achieving a complete response (CR), defined as no emesis and no rescue medications in the 0-120 hour time period following weekly intravenous doxorubicin.
III. To determine the number of emetic episodes daily and cumulatively for the 24-120, and 0-120 hour time periods.
IV. To determine the time to first emetic episode. V. To determine the time to first administration of rescue medication. VI. To determine the time to treatment failure (time to first emetic episode or administration of rescue medication, whichever occurred first).
VII. To determine the number of doses of rescue medications used. VIII. To determine the side effects of antiemetic medications used. IX. To determine theseverity of nausea. X. To evaluate quality of life.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
GROUP I: Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
GROUP II: Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Treatment repeats every 7 days for 12-15 courses in the absence of disease progression or unacceptable toxicity.
- Conditions
- Male Breast Cancer, Nausea and Vomiting, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
- Being tested
- palonosetron hydrochloride, cyclophosphamide, dexamethasone, doxorubicin hydrochloride, quality-of-life assessment
- Medical subject headings
- Breast Neoplasms, Male, Nausea, Vomiting, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palonosetron hydrochlorideDrug
Also called Aloxi, RS 25259-197
Given IV
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
Given orally
dexamethasoneDrug
Also called Aeroseb-Dex, Decaderm, Decadron, DM
Given orally or IV
Also called ADM, ADR, Adria, Adriamycin PFS
Given IV
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
nausea and vomiting therapyProcedure or surgery
Also called antiemetic support, management of nausea and vomiting, nausea and vomiting management, therapy, nausea and vomiting
Given IV
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Given IV
ondansetron hydrochlorideDrug
Also called GR 38032F, GR-C507/75, SN-307, Zofran
Given IV
survey administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone + Ondansetron IV on Day 1 | Active comparator | All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride). Receives: Drug: cyclophosphamide; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Procedure: quality-of-life assessment; Procedure: nausea and vomiting therapy; Procedure: management of therapy complications; Drug: ondansetron hydrochloride; Other: survey administration |
| Dexamethasone + Palonosetron IV on Day 1 | Experimental | All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride). Receives: Drug: palonosetron hydrochloride; Drug: cyclophosphamide; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Procedure: quality-of-life assessment; Procedure: nausea and vomiting therapy; Procedure: management of therapy complications; Other: survey administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Patients Achieving a Complete Response
Measured: At 0-24 hours after weekly intravenous doxorubin
Secondary outcomes (8)
Count of Patients Achieving Complete Response
Measured: At 24-120 hours after weekly intravenous doxorubicin
Number of Days With Emetic Episodes and Rescue Medicines
Measured: Up to 3 months
Number of Participants That Had Emesis Within 48 Hours of Chemotherapy
Count of patients that had emesis within 48 hours of chemotherapy
Measured: Up to 48 hours of chemotherapy
Number of Participants That Had First Administration of Rescue Medication Within 48 Hours
Count of patients that had first administration of rescue medication within 48 Hours
Measured: up to 48 hours of chemotherapy
Number of Doses of Rescue Medications Used
Measured: Days 1-7 of each cycle
Side Effects of Antiemetic Medications Used
Measured: Up to 3 months
Severity of Nausea
Count of participants with severe nausea
Measured: Up to 3 months
Quality of Life
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2010
- Study completionDec 2010
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.
- Other trials for Male Breast CancerStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Hannah Linden, University of Washington
- Investigators
- Hannah Linden, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343863
- Sponsor's protocol ID
- 6140
- Other IDs
- NCI-2010-00801
- Status last verified
- Jun 2017
- First submitted
- 22 Jun 2006
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Palonosetron in the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting Following Dose Dense Adriamycin-Cyclophosphamide Chemotherapy in Early Stage Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00343863
- Acronym / sponsor ID
- 6140
- Conditions
- Male Breast Cancer, Nausea and Vomiting, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Jun 2006 (estimated)
- Results
- Posted 11 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Antiemetic drugs, such as dexamethasone, ondansetron hydrochloride, and palonosetron hydrochloride, may help lessen or prevent nausea and vomiting caused by chemotherapy.
PURPOSE: This clinical trial studies how well giving dexamethasone together with ondansetron hydrochloride or palonosetron hydrochloride works in preventing nausea and vomiting in patients receiving doxorubicin hydrochloride and cyclophosphamide for early stage breast cancer
Detailed description
PRIMARY OBJECTIVES:
- To determine the proportion of patients achieving a complete response (CR), defined as no emesis and no rescue medications in the 0-24 hour time period following weekly intravenous doxorubicin.
SECONDARY OBJECTIVES:
- To determine the proportion of patients achieving a complete response (CR), defined as no emesis and no rescue medications in the 24-120 hour time period following weekly intravenous doxorubicin.
II. To determine the proportion of patients achieving a complete response (CR), defined as no emesis and no rescue medications in the 0-120 hour time period following weekly intravenous doxorubicin.
III. To determine the number of emetic episodes daily and cumulatively for the 24-120, and 0-120 hour time periods.
IV. To determine the time to first emetic episode. V. To determine the time to first administration of rescue medication. VI. To determine the time to treatment failure (time to first emetic episode or administration of rescue medication, whichever occurred first).
VII. To determine the number of doses of rescue medications used. VIII. To determine the side effects of antiemetic medications used. IX. To determine theseverity of nausea. X. To evaluate quality of life.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
GROUP I: Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
GROUP II: Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Treatment repeats every 7 days for 12-15 courses in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone + Ondansetron IV on Day 1 | Active comparator | Drug: cyclophosphamide, Drug: dexamethasone, Drug: doxorubicin hydrochloride, Procedure: quality-of-life assessment, Procedure: nausea and vomiting therapy, Procedure: management of therapy complications, Drug: ondansetron hydrochloride, Other: survey administrationAll patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride). |
| Dexamethasone + Palonosetron IV on Day 1 | Experimental | Drug: palonosetron hydrochloride, Drug: cyclophosphamide, Drug: dexamethasone, Drug: doxorubicin hydrochloride, Procedure: quality-of-life assessment, Procedure: nausea and vomiting therapy, Procedure: management of therapy complications, Other: survey administrationAll patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have a histologically confirmed diagnosis of primary breast carcinoma
- Patient must be naive to chemotherapy at the time of enrollment
- Patients must have prescribed weekly intravenous adriamycin (doxorubicin) and daily oral cyclophosphamide treatment for early breast cancer
- The patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- Patients must have a Karnofsky index of greater than or equal to 50%
Key exclusion criteria (8 listed)
- Receipt of investigational drug within 30 days before study entry
- Received any drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent (with the exception of administration of the palonosetron/dexamethasone infusion solution), including the following: 5-HT3 receptor antagonists; dopamine receptor antagonists (metoclopramide); phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide (diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of Taxanes); all benzodiazepines; haloperidol, droperidol, tetrahydrocannabinol, or nabilone; any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone) (topical or inhaled preparations are allowed)
- Any vomiting, retching or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea in the 24 hours preceding chemotherapy
- Ongoing vomiting from any organic etiology
- Need to receive systemic corticosteroids, except: a) when defined as part of the chemotherapy regimen as a preventative measure for chemotherapy toxicities; b) topical or inhaled preparations; and/or c) when used as rescue medication during the study
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 |
|---|---|---|
| palonosetron hydrochlorideAlso: Aloxi, RS 25259-197Given IV | Drug | Dexamethasone + Palonosetron IV on Day 1 |
| cyclophosphamideAlso: CPM, CTX, Cytoxan, EndoxanGiven orally | Drug | Dexamethasone + Ondansetron IV on Day 1, Dexamethasone + Palonosetron IV on Day 1 |
| dexamethasoneAlso: Aeroseb-Dex, Decaderm, Decadron, DMGiven orally or IV | Drug | Dexamethasone + Ondansetron IV on Day 1, Dexamethasone + Palonosetron IV on Day 1 |
| doxorubicin hydrochlorideAlso: ADM, ADR, Adria, Adriamycin PFSGiven IV | Drug | Dexamethasone + Ondansetron IV on Day 1, Dexamethasone + Palonosetron IV on Day 1 |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Dexamethasone + Ondansetron IV on Day 1, Dexamethasone + Palonosetron IV on Day 1 |
| nausea and vomiting therapyAlso: antiemetic support, management of nausea and vomiting, nausea and vomiting management, therapy, nausea and vomitingGiven IV | Procedure or surgery | Dexamethasone + Ondansetron IV on Day 1, Dexamethasone + Palonosetron IV on Day 1 |
| management of therapy complicationsAlso: complications of therapy, management ofGiven IV | Procedure or surgery | Dexamethasone + Ondansetron IV on Day 1, Dexamethasone + Palonosetron IV on Day 1 |
| ondansetron hydrochlorideAlso: GR 38032F, GR-C507/75, SN-307, ZofranGiven IV | Drug | Dexamethasone + Ondansetron IV on Day 1 |
| survey administrationAncillary studies | Other | Dexamethasone + Ondansetron IV on Day 1, Dexamethasone + Palonosetron IV on Day 1 |
Primary outcome
Count of Patients Achieving a Complete Response
Time frame: At 0-24 hours after weekly intravenous doxorubin
8 secondary outcomes
Count of Patients Achieving Complete Response
Time frame: At 24-120 hours after weekly intravenous doxorubicin
Number of Days With Emetic Episodes and Rescue Medicines
Time frame: Up to 3 months
Number of Participants That Had Emesis Within 48 Hours of Chemotherapy
Time frame: Up to 48 hours of chemotherapy
Number of Participants That Had First Administration of Rescue Medication Within 48 Hours
Time frame: up to 48 hours of chemotherapy
Number of Doses of Rescue Medications Used
Time frame: Days 1-7 of each cycle
Side Effects of Antiemetic Medications Used
Time frame: Up to 3 months
Severity of Nausea
Time frame: Up to 3 months
Quality of Life
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hannah Linden principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing palonosetron hydrochloride, cyclophosphamide and dexamethasone in people with Male Breast Cancer and Nausea and Vomiting, 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 6 inclusion and 8 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 11 Jul 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2017). 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?
Count of Patients Achieving a Complete Response (time frame: At 0-24 hours after weekly intravenous doxorubin). 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 11 Jul 2017.