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Nausea and VomitingNCT01275664

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

A study testing Adjuvant Therapy, Aprepitant and Carboplatin in people with Nausea and Vomiting and Ovarian Brenner Tumor, run by Gynecologic Oncology Group at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Adjuvant Therapy, Aprepitant and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
2 sitesUnited States
Study dates
Jun 2011to May 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)
Show all 21Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Sudarshan K Sharma MD Limted-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

Other trials in United States

About this study

Official title: Pilot Study of Standard Therapy for Prevention of Nausea and Emesis Associated With First Line Post-Operative Intraperitoneal Chemotherapy

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Medical subject headings
Nausea, Vomiting, Brenner Tumor, Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvant TherapyProcedure or surgery

    Also called adjunct therapy, adjunctive therapy

    Ancillary studies

  • AprepitantDrug

    Also called Emend, L-754030, MK-0869, ONO-7436

    Given IV and PO

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IP

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IP

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • Granisetron Transdermal PatchDrug

    Also called Granisetron Transdermal System, Sancuso

    Apply one patch to upper arm

  • Management of Therapy ComplicationsProcedure or surgery

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT01275664
Study groupRoleWhat they receive
Treatment (granisetron, dexamethasone, aprepitant)ExperimentalPatients 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.
Receives: Procedure: Adjuvant Therapy; Drug: Aprepitant; Drug: Carboplatin; Drug: Cisplatin; Drug: Dexamethasone; Drug: Granisetron Transdermal Patch; Procedure: Management of Therapy Complications; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis)

    Number of participants who had complete control defined by no vomiting

    Measured: During the 6 days following chemotherapy

Secondary outcomes (4)

  1. Change in Vomiting, Nausea and Total FLIE Scores

    Measured: Baseline to day 6

  2. Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0

    Adverse events at least possibly related to treatment

    Measured: Up to day 6

  3. Mean and Standard Deviation of Vomiting, Nausea, and Total FLIE Scores

    Measured: Baseline

  4. Percentages of Patients With NIDL Based on FLIE

    Measured: Up to day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionMay 2014

Why it stopped: Study terminated due to no patient population available

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01275664
Sponsor's protocol ID
GOG-0272
Other IDs
NCI-2011-02660, CDR0000692516, GOG-0272, GOG-0272, GOG-0272, U10CA101165
Status last verified
May 2017
First submitted
11 Jan 2011
Last updated
22 May 2018

Questions about this trial

What is this clinical trial studying?

A study testing Adjuvant Therapy, Aprepitant and Carboplatin in people with Nausea and Vomiting and Ovarian Brenner Tumor, run by Gynecologic Oncology Group at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis) (time frame: During the 6 days following chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01275664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.

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