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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00343863 |
Purpose
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
| Condition | Intervention |
|---|---|
|
Male Breast Cancer Nausea and Vomiting Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer |
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 Drug: ondansetron hydrochloride Other: survey administration |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
| Estimated Enrollment: | 57 |
| Study Start Date: | January 2006 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I
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). |
Drug: palonosetron hydrochloride
Given IV
Other Names:
Drug: cyclophosphamide
Given orally
Other Names:
Drug: dexamethasone
Given orally or IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Procedure: nausea and vomiting therapy
Given IV
Other Names:
Procedure: management of therapy complications
Given IV
Other Name: complications of therapy, management of
Drug: ondansetron hydrochloride
Given IV
Other Names:
Other: survey administration
Ancillary studies
|
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| Seattle, Washington, United States, 98109 | |
| Principal Investigator: | Hannah Linden | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
| Responsible Party: | Linden, Hannah, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT00343863 History of Changes |
| Other Study ID Numbers: | 6140, NCI-2010-00801 |
| Study First Received: | June 22, 2006 |
| Last Updated: | September 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Breast Neoplasms Nausea Vomiting Breast Neoplasms, Male Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Signs and Symptoms, Digestive Signs and Symptoms Antiemetics Dexamethasone Ondansetron Cyclophosphamide Doxorubicin |
Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Palonosetron Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating |
