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Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical Cancer Receiving Chemoradiation


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Cancer of the Cervix

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Trial Information

Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical Cancer Receiving Chemoradiation


Study Groups:

If you agree to take part in this study, and you are among the first 40 participants, you
will have an equal chance of being in either group. If you enroll after that, you will have
a higher chance (51%-100%) of being assigned to the group that had better results.

- If you are in Group 1, you will receive granisetron by patch.

- If you are in Group 2, you will receive ondansetron by mouth.

Study Drug Administration:

If you are in Group 1, you will receive ondansetron by vein at your first visit only, which
is standard of care. Then, you will receive cisplatin by vein over about 1 hour as part of
the chemoradiation. A granisetron patch will then be placed on your skin before the
chemotherapy . The patch will be replaced every 7 days before the chemotherapy.

If you are in Group 2, you will receive ondansetron by vein before cisplatin. Then, you
will receive cisplatin by vein over about 1 hour. Then you will take ondansetron by mouth
with a cup of water (8 ounces) 3 times a day for 3 days. Ondansetron is a tablet that you
can take with or without food and is best taken at least 30 minutes before eating.

Both groups will be given a study drug diary to record the times that you take the study
drugs. You will also record any nausea or vomiting that you may have. You should bring the
diary to each study visit. You should also bring your study drug bottles/packages to each
study visit.

Study Visits:

The visits for this study will be at the same time as your chemoradiation therapy visits
over 5 weeks.

You will complete 3 questionnaires at your study visits and then again 1 week after the
last chemotherapy. The last questionnaires will be completed by phone. The questionnaires
ask about how easy or difficult it is to use your assigned study drug, your level of nausea
and vomiting, and your quality of life. It should take about 5 minutes to complete these
questionnaires each time.

Length of Treatment:

You may continue using the study drug up to 5 weeks during your chemoradiation treatment.
You will no longer be able to take the study drug if the disease gets worse, if intolerable
side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over when you have completed 5 weeks of
chemoradiation treatments.

This is an investigational study. Both granisetron and ondansetron are FDA approved and
commercially available for the treatment of nausea and vomiting. It is investigational to
compare these drugs administered in different ways.

Up to 150 patients will take part in this study. Up to 138 participants will take part at
MD Anderson. Up to 12 participants will take part at Lyndon B. Johnson General Hospital.


Inclusion Criteria:



1. Women with biopsy-proven, locally advanced (stages IA2-IVA) cervical cancer
dispositioned to receive definitive pelvic radiation therapy with concurrent
cisplatin administration.

2. Women receiving primary or adjuvant pelvic radiation with concurrent cisplatinum
postoperatively for cervical or endometrial cancer.

3. Women must be at least 18 years of age.

4. Women must be able to read English or Spanish at a sixth grade level.

5. Women with childbearing potential must have a negative pregnancy test within 1 week
of starting chemoradiation therapy

Exclusion Criteria:

1. Women with cervical or endometrial cancer who are receiving chemotherapy and/or
radiation therapy for recurrent disease.

2. Women with cervical or endometrial cancer who are receiving extended field radiation
therapy

3. Women with cervical or endometrial cancer who are receiving chemotherapy and/or
radiation therapy in a palliative setting

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to Anti-Emetic Therapy

Outcome Description:

Response defined as no emetic or retching episodes and no rescue medication use during late onset phase (4-7 days post-chemotherapy) measured each cycle. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy.

Outcome Time Frame:

Day 7

Safety Issue:

No

Principal Investigator

Michael M. Frumovitz, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2011-1107

NCT ID:

NCT01536392

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Cancer of the Cervix
  • Cancer of the Cervix
  • Anti-emetic therapy
  • Granisetron
  • Transdermal patch
  • Ondansetron
  • Zofran
  • Questionnaires
  • Surveys
  • Study Drug Diary
  • Uterine Cervical Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030