Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01275664
First received: January 11, 2011
Last updated: May 27, 2015
Last verified: May 2015
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention
Fallopian Tube Cancer
Nausea and Vomiting
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: aprepitant
Drug: carboplatin
Drug: cisplatin
Drug: dexamethasone
Drug: granisetron transdermal system
Other: questionnaire administration
Procedure: adjuvant therapy
Procedure: management of therapy complications

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study of Standard Therapy for Prevention of Nausea and Emesis Associated With First Line Post-Operative Intraperitoneal Chemotherapy

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Complete control of chemotherapy-induced nausea and vomiting [ Time Frame: days 1-6 following chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean of patients with vomiting, nausea, and total Functional Living Index--Emesis (FLIE) scores [ Time Frame: days 1-6 following chemotherapy ] [ Designated as safety issue: No ]
  • Percentages of patients with no impact on daily living (NIDL) based on FLIE [ Time Frame: days 1-6 following chemotherapy ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by the NCI CTCAE v 4.0 [ Time Frame: days 1-6 following chemotherapy ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: June 2011
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IP Cisplatin
Enrolled on GOG-0252 IP Cisplatin and receiving sancuso patch, dexamethasome and aprepitant
Drug: aprepitant Drug: cisplatin Drug: dexamethasone Drug: granisetron transdermal system Other: questionnaire administration Procedure: adjuvant therapy Procedure: management of therapy complications
IP Carboplatin
Enrolled on GOG-0252 IP Carboplatin and receiving sancuso patch, dexamethasome and aprepitant
Drug: aprepitant Drug: carboplatin Drug: dexamethasone Drug: granisetron transdermal system Other: questionnaire administration Procedure: adjuvant therapy Procedure: management of therapy complications

Detailed Description:

OBJECTIVES:

Primary

  • 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

  • To evaluate possible endpoints for the chemotherapy-induced nausea and vomiting, including Functional Living Index-Emesis (FLIE) questionnaire scores.
  • To evaluate mean vomiting, nausea, and total FLIE scores and changes from baseline in FLIE scores.
  • To evaluate the percentage of patients with no impact on daily living (NIDL) (i.e., > 108/126 total FLIE score).
  • 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. The granisetron patch is removed on day 7.

Patients complete the Functional Living Index--Emesis (FLIE) and a symptom diary at baseline and on days 3 and 6.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

    • Stage II, III, or IV disease
  • Patients must be receiving the 1 of the following initial courses of chemotherapy:

    • Paclitaxel 135 mg/m² IV over 3 hours on day 1 and cisplatin 75 mg/m² intraperiotoneally (IP) on day 2
    • Paclitaxel 80 mg/m² IV days 1, 8, and 15 and carboplatin area under the curve (AUC) 6 IP on day 1

PATIENT CHARACTERISTICS:

  • Able to read, understand, and write English
  • Able to complete the assessments
  • Able to comply with the anti-emetic therapy
  • No known hypersensitivity to aprepitant (injectable or oral), granisetron, any of the components of the patch, or dexamethasone
  • No patients who, in the opinion of the treating physician, have a medical condition, or currently take medications that are felt to contraindicate safe or effective administration of the standard three-drug anti-emetic regimen used in this study

    • Examples of this would be hearing loss or neuropathy that would prevent tolerance to cisplatin and paclitaxel administration
  • No patients who are pregnant or nursing
  • No patients with clinical symptoms or signs of gastrointestinal obstruction and/ or those who require parenteral hydration and/or nutrition
  • No patients with history or current diagnosis of inflammatory bowel disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded

    • Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor, including neo-adjuvant chemotherapy for their ovarian or primary peritoneal cancer, are excluded

    • Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01275664

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Steven C. Plaxe, MD University of California, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01275664     History of Changes
Other Study ID Numbers: GOG-0272, GOG-0272, CDR0000692516, NCI-2011-02660
Study First Received: January 11, 2011
Last Updated: May 27, 2015
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
nausea and vomiting
stage IIA ovarian epithelial cancer
stage IIB ovarian epithelial cancer
stage IIC ovarian epithelial cancer
stage IIIA ovarian epithelial cancer
stage IIIB ovarian epithelial cancer
stage IIIC ovarian epithelial cancer
stage IV ovarian epithelial cancer
stage IIA fallopian tube cancer
stage IIB fallopian tube cancer
stage IIC fallopian tube cancer
stage IIIA fallopian tube cancer
stage IIIB fallopian tube cancer
stage IIIC fallopian tube cancer
stage IV fallopian tube cancer
stage IIA primary peritoneal cavity cancer
stage IIB primary peritoneal cavity cancer
stage IIC primary peritoneal cavity cancer
stage IIIA primary peritoneal cavity cancer
stage IIIB primary peritoneal cavity cancer
stage IIIC primary peritoneal cavity cancer
stage IV primary peritoneal cavity cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Nausea
Ovarian Neoplasms
Peritoneal Neoplasms
Vomiting
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Urogenital Neoplasms
Aprepitant
BB 1101
Carboplatin
Cisplatin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Fosaprepitant

ClinicalTrials.gov processed this record on July 01, 2015