Clinical trial NCT01275664
Conditions: Nausea and Vomiting Ovarian Brenner Tumor Ovarian Clear Cell Cystadenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Cystadenocarcinoma Ovarian Seromucinous Carcinoma Ovarian Serous Cystadenocarcinoma Stage II Ovarian Cancer Stage IIA Fallopian Tube Cancer Stage IIA Ovarian Cancer Stage IIB Fallopian Tube Cancer Stage IIB Ovarian Cancer Stage IIC Fallopian Tube Cancer Stage IIC Ovarian Cancer Stage IIIA Fallopian Tube Cancer Stage IIIA Ovarian Cancer Stage IIIA Primary Peritoneal Cancer Stage IIIB Fallopian Tube Cancer Stage IIIB Ovarian Cancer Stage IIIB Primary Peritoneal Cancer Stage IIIC Fallopian Tube Cancer Stage IIIC Ovarian Cancer Stage IIIC Primary Peritoneal Cancer Stage IV Fallopian Tube Cancer Stage IV Ovarian Cancer Stage IV Primary Peritoneal Cancer Undifferentiated Ovarian Carcinoma
Sponsor: Gynecologic Oncology Group
Start date: 2011-06-01; Completion date: 2014-05-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed 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:

* Functional Living Index-Emesis (FLIE) questionnaire scores
* Mean vomiting, nausea and total FLIE scores and changes from baseline in FLIE scores
* Percentages of patients with no impact on daily living (NIDL), i.e. \> 108/126 total FLIE score II. To describe the timing of nausea and vomiting that may guide modifications to the standard regimen.

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.

Arms: arm 1: 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 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.
Interventions: intervention 1: Adjuvant Therapy intervention 2: Aprepitant intervention 3: Carboplatin intervention 4: Cisplatin intervention 5: Dexamethasone intervention 6: Granisetron Transdermal Patch intervention 7: Management of Therapy Complications intervention 8: Questionnaire Administration
Intervention descriptions: intervention 1: Ancillary studies intervention 2: Given IV and PO intervention 3: Given IP intervention 4: Given IP intervention 5: Given PO intervention 6: Apply one patch to upper arm intervention 7: Ancillary studies intervention 8: Ancillary studies

Protocol documents: