Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02550119
Other study ID # 3C-06-1
Secondary ID NCI-2012-017403C
Status Terminated
Phase N/A
First received September 13, 2015
Last updated March 24, 2017
Start date April 19, 2006
Est. completion date April 1, 2010

Study information

Verified date March 2017
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 19
Est. completion date April 1, 2010
Est. primary completion date April 1, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Aprepitant
Given PO
Dexamethasone
Given PO or IV
Dolasetron Mesylate
Given PO or IV
Placebo
Given PO

Locations

Country Name City State
United States USC / Norris Comprehensive Cancer Center Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Proportion of patients who agreed to be randomized out of all patients who qualify for randomization 28 days
See also
  Status Clinical Trial Phase
Recruiting NCT05016180 - Effect of Ultrasound-guided Transversus Abdominis Plane Block After Laparoscopic Bariatric Surgery Phase 2
Withdrawn NCT00891761 - A Study of IV Casopitant for the Prevention of Nausea and Vomiting Caused By Cisplatin-Based Highly Emetogenic Chemotherapy Phase 3
Terminated NCT00903396 - Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer Phase 2
Completed NCT05533281 - Efficacy of Three Antiemetics in Preventing Nausea and Vomiting Phase 4
Recruiting NCT01696734 - Domperidone in Treating Patients With Gastrointestinal Disorders Phase 3
Completed NCT00293384 - Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant N/A
Completed NCT00006348 - Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment Phase 3
Completed NCT00003817 - Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy Phase 2
Completed NCT00004895 - Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery Phase 2
Active, not recruiting NCT06045364 - Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation Phase 1/Phase 2
Completed NCT00978185 - Acupressure Wristbands or Standard Care in Controlling Nausea Caused by Chemotherapy Phase 3
Completed NCT00064272 - UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer Phase 2
Completed NCT00003213 - Drugs to Reduce the Side Effects of Chemotherapy Phase 3
Recruiting NCT05690802 - The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV N/A
Recruiting NCT06314906 - Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer Phase 3
Completed NCT00590317 - Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department Phase 2
Completed NCT03185156 - The Preventive Effects of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate Phase 4
Not yet recruiting NCT06382012 - Antiemetic Fosaprepitant To Remedy Nausea and Vomiting Phase 2/Phase 3
Completed NCT01590147 - Supportive Intervention Programs Study N/A
Terminated NCT01275664 - Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer N/A