Back to results

Dolasetron Mesylate and Dexamethasone With or Without Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Oxaliplatin-Containing Chemotherapy for Gastrointestinal Malignancy

Primary Purpose

Malignant Digestive System Neoplasm, Nausea and Vomiting

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aprepitant

Dexamethasone

Dolasetron Mesylate

Placebo

About this trial

This is an interventional supportive care trial for Malignant Digestive System Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who have a diagnosis of GI malignancy and who are scheduled to receive their initial treatment with an oxaliplatin-containing regimen in combination with 5-fluorouracil; these include combinations such as fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX), FOLFOX + bevacizumab, FOLFOX + cetuximab
Standard antiemetic therapy with initial treatment must include the dolasetron and dexamethasone; the minimum adequate doses include either:
- Dolasetron (Anzemet) 100mg PO/IV or 1.8mg/kg IV AND
- Dexamethasone (Decadron) 10mg PO/IV
Patient must agree, as part of the informed consent, to keep a journal of the episodes of nausea, vomiting, retching, and amount of rescue medications used on days 1 to 5 (day 1 = day of treatment)
Signed informed consent

Exclusion Criteria:

Allergy or intolerance to dolasetron and dexamethasone
Use of another antiemetic agent (5HT3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours of day 1 of the study
An episode of vomiting or retching within 24 hours before the start of the initial treatment with oxaliplatin-containing regimen
Severe concurrent illness other than neoplasia
Gastrointestinal obstruction or an active peptic ulcer
Radiation therapy to the abdomen or pelvis within 1 week before or after day 1 of the study
Absolute neutrophil count of less than 1.5 x 10^9/L (unless physician approves to proceed with chemotherapy) or
Platelets less than 100 x 109/L (unless physician approves to proceed with chemotherapy)
Total bilirubin > 2 x upper limits of normal
Patients who are pregnant or breast feeding
Patients who are non-English speaking
Patients with cancer-induced nausea and vomiting grade 1 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria

Sites / Locations

USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (aprepitant, dolasetron mesylate, dexamethasone)

Arm II (placebo, dolasetron mesylate, dexamethasone)

Arm Description

Patients receive dolasetron mesylate PO or IV, dexamethasone PO or IV, and aprepitant PO 1 day before chemotherapy and dexamethasone PO and aprepitant PO on days 2 and 3 after chemotherapy begins during course 2-3.

Patients receive dolasetron mesylate and dexamethasone as in Arm I and placebo PO 1 day before chemotherapy and dexamethasone PO and placebo PO on days 2 and 3 after chemotherapy begins during courses 2-3.

Outcomes

Primary Outcome Measures

Proportion of patients with complete response, defined as no emesis and no use of rescue medication

We will summarize the incidence, severity and time of onset of all nausea and vomiting experienced by all patients who received any oxaliplatin. The complete response rates in both arms will be calculated with 95% confidence intervals.

Secondary Outcome Measures

Proportion of patients who agreed to be randomized out of all patients who qualify for randomization

Full Information

NCT ID

NCT02550119

First Posted

September 13, 2015

Last Updated

March 24, 2017

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02550119

Brief Title

Dolasetron Mesylate and Dexamethasone With or Without Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Oxaliplatin-Containing Chemotherapy for Gastrointestinal Malignancy

Official Title

A Pilot Study to Evaluate the Safety and Efficacy of Aprepitant in Combination With Dolasetron and Dexamethasone for the Prevention of Nausea and Vomiting Following Oxaliplatin-containing Regimen Which Includes 5-FU.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Why Stopped

Insufficient accrual

Study Start Date

April 19, 2006 (Actual)

Primary Completion Date

April 1, 2010 (Actual)

Study Completion Date

April 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This randomized pilot clinical trial dolasetron mesylate and dexamethasone with or without aprepitant in preventing nausea and vomiting in patients undergoing oxaliplatin-containing chemotherapy for gastrointestinal malignancy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. It is not yet known whether giving aprepitant together with dolasetron mesylate and dexamethasone is more effective than dolasetron mesylate and dexamethasone alone in preventing nausea and vomiting.

Detailed Description

PRIMARY OBJECTIVES: I. To estimate the incidence and severity of acute and delayed nausea and vomiting associated with oxaliplatin-containing regimens in patients with gastrointestinal (GI) malignancy. II. To estimate the percent of patients who have experienced nausea and vomiting with their first or second cycle of oxaliplatin-containing regimen, and would consent to randomization to standard antiemetic therapy with or without aprepitant. III. To obtain preliminary data on the safety and efficacy of aprepitant, in combination with dolasetron (dolasetron mesylate) and dexamethasone, in patients receiving oxaliplatin-containing regimen. IV. To report on medication compliance with antiemetic medications (dexamethasone and aprepitant or placebo) scheduled to be taken at home on days 2 and 3 for all randomized patients (day 1 = day of treatment). OUTLINE: Patients receive standard antiemetics comprising dolasetron mesylate orally (PO) or intravenously (IV) and dexamethasone PO or IV during course 1 of oxaliplatin-containing chemotherapy. Patients experiencing any grade 1-4 nausea and vomiting* are randomized to 1 of 2 treatment arms. ARM I: Patients receive dolasetron mesylate PO or IV, dexamethasone PO or IV, and aprepitant PO 1 day before chemotherapy and dexamethasone PO and aprepitant PO on days 2 and 3 after chemotherapy begins during course 2-3. ARM II: Patients receive dolasetron mesylate and dexamethasone as in Arm I and placebo PO 1 day before chemotherapy and dexamethasone PO and placebo PO on days 2 and 3 after chemotherapy begins during courses 2-3. In both arms, treatment continues in the absence of unacceptable toxicity. NOTE: * Patients not developing nausea and vomiting until the second course of treatment are also randomized during courses 3 and 4 of chemotherapy. After completion of study treatment, patients are followed up periodically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Digestive System Neoplasm, Nausea and Vomiting

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (aprepitant, dolasetron mesylate, dexamethasone)

Arm Type

Experimental

Arm Description

Arm Title

Arm II (placebo, dolasetron mesylate, dexamethasone)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Aprepitant

Other Intervention Name(s)

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

Intervention Description

Given PO

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, Visumetazone

Intervention Description

Given PO or IV

Intervention Type

Drug

Intervention Name(s)

Dolasetron Mesylate

Other Intervention Name(s)

Anzemet, MDL 73,147EF

Intervention Description

Given PO or IV

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

PLCB, sham therapy

Intervention Description

Given PO

Primary Outcome Measure Information:

Title

Proportion of patients with complete response, defined as no emesis and no use of rescue medication

Description

Time Frame

Within the first 24 hours of treatment (day 1)

Secondary Outcome Measure Information:

Title

Proportion of patients who agreed to be randomized out of all patients who qualify for randomization

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who have a diagnosis of GI malignancy and who are scheduled to receive their initial treatment with an oxaliplatin-containing regimen in combination with 5-fluorouracil; these include combinations such as fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX), FOLFOX + bevacizumab, FOLFOX + cetuximab Standard antiemetic therapy with initial treatment must include the dolasetron and dexamethasone; the minimum adequate doses include either: Dolasetron (Anzemet) 100mg PO/IV or 1.8mg/kg IV AND Dexamethasone (Decadron) 10mg PO/IV Patient must agree, as part of the informed consent, to keep a journal of the episodes of nausea, vomiting, retching, and amount of rescue medications used on days 1 to 5 (day 1 = day of treatment) Signed informed consent Exclusion Criteria: Allergy or intolerance to dolasetron and dexamethasone Use of another antiemetic agent (5HT3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours of day 1 of the study An episode of vomiting or retching within 24 hours before the start of the initial treatment with oxaliplatin-containing regimen Severe concurrent illness other than neoplasia Gastrointestinal obstruction or an active peptic ulcer Radiation therapy to the abdomen or pelvis within 1 week before or after day 1 of the study Absolute neutrophil count of less than 1.5 x 10^9/L (unless physician approves to proceed with chemotherapy) or Platelets less than 100 x 109/L (unless physician approves to proceed with chemotherapy) Total bilirubin > 2 x upper limits of normal Patients who are pregnant or breast feeding Patients who are non-English speaking Patients with cancer-induced nausea and vomiting grade 1 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Betty Chan

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

Facility Information:

Facility Name

USC / Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Dolasetron Mesylate and Dexamethasone With or Without Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Oxaliplatin-Containing Chemotherapy for Gastrointestinal Malignancy

We'll reach out to this number within 24 hrs