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

NCT02550119 | Terminated DMC

• 3 other identifiers: 3C-06-1NCI-2012-01740P30CA014089
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Digestive System Neoplasm; Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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.

  Within the first 24 hours of treatment (day 1)

Secondary Outcomes (1)

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

  28 days

Study Arms (2)

Arm I (aprepitant, dolasetron mesylate, dexamethasone)

EXPERIMENTAL

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.

Drug: Aprepitant; Drug: Dexamethasone; Drug: Dolasetron Mesylate

Arm II (placebo, dolasetron mesylate, dexamethasone)

PLACEBO COMPARATOR

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.

Drug: Dexamethasone; Drug: Dolasetron Mesylate; Drug: Placebo

Interventions

Aprepitant DRUG

Given PO

Also known as: Emend, L-754030, MK-0869, ONO-7436

Arm I (aprepitant, dolasetron mesylate, dexamethasone)

Dexamethasone DRUG

Given PO or IV

Also known as: 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

Arm I (aprepitant, dolasetron mesylate, dexamethasone); Arm II (placebo, dolasetron mesylate, dexamethasone)

Dolasetron Mesylate DRUG

Given PO or IV

Also known as: Anzemet, MDL 73,147EF

Arm I (aprepitant, dolasetron mesylate, dexamethasone); Arm II (placebo, dolasetron mesylate, dexamethasone)

Placebo DRUG

Given PO

Also known as: PLCB, sham therapy

Arm II (placebo, dolasetron mesylate, dexamethasone)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Nausea; Vomiting

Interventions

Aprepitant; Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; dolasetron

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Betty Chan

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2015
• First Posted: September 15, 2015
• Study Start: April 19, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

US (1)