Clinical trial NCT01275664: Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer
Official title: Pilot Study of Standard Therapy for Prevention of Nausea and Emesis Associated With First Line Post-Operative Intraperitoneal Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-01-12
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis)
timeFrame: During the 6 days following chemotherapy
Secondary outcomes:
measure: Change in Vomiting, Nausea and Total FLIE Scores
timeFrame: Baseline to day 6
measure: Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0
timeFrame: Up to day 6
measure: Mean and Standard Deviation of Vomiting, Nausea, and Total FLIE Scores
timeFrame: Baseline
measure: Percentages of Patients With NIDL Based on FLIE
timeFrame: Up to day 6
Other outcomes:
Locations:
city: Hinsdale
country: United States
facility: Sudarshan K Sharma MD Limted-Gynecologic Oncology
state: Illinois
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
affiliation: NRG Oncology
name: Steven Plaxe
role: PRINCIPAL_INVESTIGATOR
References: