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Oral Versus Transdermal Ondansetron for Women With Cervical Cancer Receiving Chemoradiation

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Sancuso
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01536392
First received: February 16, 2012
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

The goal of this clinical research study is to compare granisetron (when given through a patch) to ondansetron (when taken by mouth) for reducing nausea and vomiting in women with cervical cancer having chemoradiation.

Granisetron and ondansetron are designed to help reduce nausea and vomiting.


Condition Intervention Phase
Cancer of the Cervix
Drug: Granisetron
Drug: Ondansetron
Behavioral: Questionnaires
Behavioral: Study Drug Diary
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical Cancer Receiving Chemoradiation

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response to Anti-Emetic Therapy [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: March 2012
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Granisetron
Group A: 34.3 mg of granisetron formulated in transdermal patch replaced every 7 days. Transdermal patch placed/replaced prior to the intravenous (IV) infusion of cisplatin. At cycle 1, participants receive IV granisetron prior to IV cisplatin and prior to administration of transdermal patch.
Drug: Granisetron
34.3 mg of granisetron formulated in a transdermal patch replaced every 7 days. At cycle 1, participants receive granisetron by vein prior to IV cisplatin and prior to administration of transdermal patch.
Behavioral: Questionnaires
Completion of 3 questionnaires at study visits taking about 5 minutes each time.
Other Name: Surveys
Behavioral: Study Drug Diary
Study drug diary to record times that study drugs taken, and to record any nausea or vomiting experienced.
Experimental: Ondansetron
Group B: 8 mg of ondansetron orally thrice daily starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.
Drug: Ondansetron
8 mg of ondansetron by mouth three times a day starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.
Other Name: Zofran
Behavioral: Questionnaires
Completion of 3 questionnaires at study visits taking about 5 minutes each time.
Other Name: Surveys
Behavioral: Study Drug Diary
Study drug diary to record times that study drugs taken, and to record any nausea or vomiting experienced.

Detailed Description:

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 the Harris Health System.

  Eligibility

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

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
  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: NCT01536392

Contacts
Contact: Michael M. Frumovitz, MD, MPH 713-792-9599

Locations
United States, Texas
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Sancuso
Investigators
Principal Investigator: Michael M. Frumovitz, MD, MPH M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01536392     History of Changes
Other Study ID Numbers: 2011-1107, NCI-2012-00221
Study First Received: February 16, 2012
Last Updated: October 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Cancer of the Cervix
Anti-emetic therapy
Granisetron
Transdermal patch
Ondansetron
Zofran
Questionnaires
Surveys
Study Drug Diary

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Granisetron
Ondansetron
Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014