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

This study has suspended participant recruitment.
(Temporarily Closed to Accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01275664
First received: January 11, 2011
Last updated: March 16, 2016
Last verified: March 2016
  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. 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.

Condition Intervention
Malignant Ovarian Mixed Epithelial Tumor
Nausea and Vomiting
Ovarian Brenner Tumor
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Cystadenocarcinoma
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
Procedure: Adjuvant Therapy
Drug: Aprepitant
Drug: Carboplatin
Drug: Cisplatin
Drug: Dexamethasone
Drug: Granisetron Transdermal Patch
Procedure: Management of Therapy Complications
Other: Questionnaire Administration

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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:
  • Frequency of complete control defined as no vomiting and no use of rescue medications (for nausea or emesis) based on the patient-completed symptom diary [ Time Frame: During the 6 days following chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in vomiting, nausea and total FLIE scores [ Time Frame: Baseline to day 6 ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by the NCI CTCAE v 4.0 [ Time Frame: Up to day 6 ] [ Designated as safety issue: Yes ]
  • Mean and standard deviation of vomiting, nausea, and total FLIE scores [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentages of patients with NIDL based on FLIE [ Time Frame: Up to day 6 ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: June 2011
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (granisetron, dexamethasone, aprepitant)
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.
Procedure: Adjuvant Therapy
Ancillary studies
Other Names:
  • adjunct therapy
  • adjunctive therapy
Drug: Aprepitant
Given IV and PO
Other Names:
  • Emend
  • L-754030
  • MK-0869
  • ONO-7436
Drug: Carboplatin
Given IP
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplat
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Drug: Cisplatin
Given IP
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
Drug: Granisetron Transdermal Patch
Apply one patch to upper arm
Other Names:
  • Granisetron Transdermal System
  • Sancuso
Procedure: Management of Therapy Complications
Ancillary studies
Other: Questionnaire Administration
Ancillary studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    • Stage II, III, or IV disease with optimal (=< 1 cm residual disease) or suboptimal residual disease
    • All patients must have a procedure for determining diagnosis of epithelial ovarian, fallopian tube, primary peritoneal, with appropriate tissue for histologic evaluation
    • The minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage, as well as a maximal effort at tumor debulking; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual
  • Patients with the following histologic epithelial cell types are eligible:

    • Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.)
    • However, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; if doubt exists, it is recommended that the investigator should have the slides reviewed by an independent pathologist prior to entry
    • Patients may have co-existing endometrial cancer so long as the primary origin of invasive tumor is ovarian or peritoneal for clarification of synchronous primary endometrial cancer
  • Patients receiving the initial course of chemotherapy including

    • Paclitaxel 135 mg/M2 IV over 3 hours on day 1 and
    • Cisplatin 75 mg/M2 IP on day 2 OR
    • Paclitaxel 80 mg/m2 IV days 1, 8 and 15 and
    • Carboplatin AUC 6 IP on day 1
  • 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

Exclusion Criteria:

  • Patients who are known to be hypersensitive to aprepitant, granisetron or any of the components of the patch or to dexamethasone
  • 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 that the patient remains free of recurrent or metastatic disease
  • Patients who are pregnant or nursing; to date, no fetal studies in animals or humans have been performed; the possibility of harm to a fetus is likely
  • Patients with clinical symptoms or signs of gastrointestinal obstruction and/ or those who require parenteral hydration and/or nutrition; patients with history or current diagnosis of inflammatory bowel disease are not eligible
  • Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; examples of this would be hearing loss or neuropathy which would prevent tolerance to cisplatin, and paclitaxel administration; the investigator should feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regard
  • Patients who, in the opinion of the treating physician, have a medical condition, or currently take medications, which are felt to contraindicate safe or effective administration of the standard three drug anti-emetic regimen used in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275664

Locations
United States, Illinois
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven Plaxe NRG Oncology
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01275664     History of Changes
Other Study ID Numbers: GOG-0272  NCI-2011-02660  CDR0000692516  GOG-0272  GOG-0272  GOG-0272  U10CA101165 
Study First Received: January 11, 2011
Last Updated: March 16, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Ovarian Neoplasms
Nausea
Vomiting
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Cystadenocarcinoma
Carcinoma, Endometrioid
Cystadenocarcinoma, Serous
Cystadenocarcinoma, Mucinous
Brenner Tumor
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2016