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This clinical trial is studying how well granisetron, aprepitant, and dexamethasone work in preventing nausea and vomiting in patients receiving chemotherapy for stage II, stage III, or stage IV ovarian cancer. Granisetron patch, aprepitant and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy for stage II, stage III, or stage IV ovarian cancer.
Full description
PRIMARY OBJECTIVES:
I. To determine the frequency of chemotherapy-induced nausea and vomiting based on complete response (no vomiting and no use of rescue therapy) during the 6 days following intraperitoneal (IP) chemotherapy for the 3-day regimen of aprepitant (both injection and capsules) in combination with granisetron transdermal system and dexamethasone in ovarian cancer patients receiving IP cisplatin OR IP carboplatin.
SECONDARY OBJECTIVES:
I. To evaluate possible endpoints for the chemotherapy-induced nausea and vomiting, including:
OUTLINE: This is a multicenter study.
Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone orally (PO) on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.
Patients complete the Functional Living Index--Emesis (FLIE) and a symptom diary at baseline and on days 3 and 6.
Enrollment
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Inclusion criteria
Diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
Patients with the following histologic epithelial cell types are eligible:
Patients receiving the initial course of chemotherapy including
Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin)
Partial thromboplastin time (PTT) < 1.5 times the upper limit of normal (heparin, lovenox or alternative anticoagulants are acceptable)
Patients with a GOG Performance Status of 0, 1, or 2
Patients who are able to read, understand and write English; if FLIE which has been translated into other languages, and validated, becomes available, then patients speaking these languages can be enrolled if translation of the symptom diary can be arranged dependent on availability of suitable translators
Patients who are able to complete the assessments
Patients who are able to comply with the anti-emetic therapy
Patients must have met pre-entry requirements
Patients must have signed an approved informed consent and authorization permitting release of personal health information
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4 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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