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Oral Versus Transdermal Ondansetron for Women With Cervical Cancer Receiving Chemoradiation

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer of the Cervix

Intervention: Granisetron (Drug); Ondansetron (Drug); Questionnaires (Behavioral); Study Drug Diary (Behavioral)

Phase: Phase 3

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Michael M. Frumovitz, MD, MPH, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Michael M. Frumovitz, MD, MPH, Phone: 713-792-9599

Summary

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.

Clinical Details

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

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

Primary outcome: Response to Anti-Emetic Therapy

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

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

Lyndon B. Johnson General Hospital, Houston, Texas 77026, United States; Recruiting

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting

Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: March 2012
Last updated: October 23, 2014

Page last updated: November 27, 2014

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