Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation

NCT01536392 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2011-1107NCI-2012-00221
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief 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, endometrial, or vaginal cancer having chemoradiation. Granisetron and ondansetron are designed to help reduce nausea and vomiting.

Conditions

Cancer of the Cervix

Keywords

Cancer of the Cervix; Anti-emetic therapy; Granisetron; Transdermal patch; Ondansetron; Zofran; Questionnaires; Surveys; Study Drug Diary; Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Response Rate to Anti-Emetic Therapy Days 4-7 Each Chemotherapy Cycle

  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. Osoba Nausea and Emesis Module; higher scores indicate worse quality of life. Morisky Medication Adherence Scale. Higher scores indicate higher compliance. Morisky Medication Adherence Scale is Yes=0 and No=1 , zero is the lowest level of medication adherence, and 4 is the highest level of medication adherence.

  Baseline, up to 7 days post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks

Secondary Outcomes (1)

• Percentage of Participants With Response Rate to Anti Emetic Therapy 0-24 Hours Each Chemotherapy Cycle

  Baseline, up to 24 hours post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks

Study Arms (2)

Granisetron

EXPERIMENTAL

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; Behavioral: Questionnaires; Behavioral: Study Drug Diary

Ondansetron

EXPERIMENTAL

Group B: 8 mg of ondansetron orally thrice daily starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.

Drug: Ondansetron; Behavioral: Questionnaires; Behavioral: Study Drug Diary

Interventions

Granisetron DRUG

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.

Granisetron

Ondansetron DRUG

8 mg of ondansetron by mouth three times a day starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.

Also known as: Zofran

Ondansetron

Questionnaires BEHAVIORAL

Completion of 3 questionnaires at study visits taking about 5 minutes each time.

Also known as: Surveys

Granisetron; Ondansetron

Study Drug Diary BEHAVIORAL

Study drug diary to record times that study drugs taken, and to record any nausea or vomiting experienced.

Granisetron; Ondansetron

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with cervical, endometrial or vaginal cancer dispositioned to receive primary or postoperative adjuvant pelvic radiation therapy with concurrent cisplatin administration.
• Women must be at least 18 years of age.
• Women must be able to read English or Spanish at a sixth grade level.
• Women with childbearing potential must have a negative pregnancy test within 1 week of starting chemoradiation therapy.

You may not qualify if:

• Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy and/or radiation therapy for recurrent disease.
• Women with cervical, endometrial, or vaginal cancer who are receiving extended field radiation therapy.
• Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy and/or radiation therapy in a palliative setting.
• Women with cervical, endometrial, or vaginal cancer who have already received their first dose of chemotherapy or radiation for more than 7 days prior to starting chemotherapy.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Sancuso: collaborator

Study Sites (2)

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Nausea; Vomiting

Interventions

Granisetron; Ondansetron; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Michael Frumovitz, Professor, Gyn Onc & Reproductive Med
• Organization: UT MD Anderson Cancer Center

mfrumovitz@mdanderson.org

(713) 792-9599

Study Officials

• Michael M. Frumovitz, MD, MPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: March 1, 2012
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: June 11, 2021
• Results First Posted: May 17, 2021

Record last verified: 2021-05

Locations

US (2)