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Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Hallym University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT01046461
First received: January 8, 2010
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis. Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and tolerability and a longer duration of effect than granisetron in preventing acute vomiting in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase emesis was less than 60%.

Aprepitant is a selective, high-affinity NK1 receptor antagonist. Adding aprepitant to 5-HT3 receptor antagonists and steroid improve CR rate of not only chemotherapy induced acute emesis and but also delayed emesis by 11-14 and 20 percentage points, respectively.

But until now, there was no information that which 5-HT3 receptor antagonists is the best partner for aprepitant. Therefore, we initiated a prospective, open-label, phase II study to assess the efficacy and tolerability of a combination of ramosetron, aprepitant and dexamethasone (RAD) in the prevention of cisplatin based CINV in chemotherapy-naïve patients with solid cancer


Condition Intervention Phase
Solid Tumour
Postoperative Nausea and Vomiting
Drug: Ramosetron, Aprepitant, Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Study to Evaluate the Efficacy and Tolerability of Ramosetron, Aprepitant and Dexamethasone (RAD) in Preventing Cisplatin-induced Nausea and Vomiting in Chemotherapy-naïve Patients With Solid Cancer

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • Complete response (CR) rate of RAD for the prevention of chemotherapy induced nausea vomiting (CINV) during overall phase (form 1 to 5 days) (overall phase is defined as acute and delayed phase) [ Time Frame: from chemotherapy day 1 to day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CR rate of RAD for the prevention of acute and delayed phase of CINV (from 0 to 24 hours /from 2 to 5 days) [ Time Frame: until 1 month after chemotherapy ] [ Designated as safety issue: Yes ]
  • Severity of nausea [ Time Frame: until 1 month after chemotherapy ] [ Designated as safety issue: Yes ]
  • Time to first occurrence of vomiting [ Time Frame: until 1 month after chemotherapy ] [ Designated as safety issue: Yes ]
  • Adverse events reported using CTCAE v3.0 [ Time Frame: until 1 month after chemotherapy ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramosetron, Aprepitant, Dexamethasone Drug: Ramosetron, Aprepitant, Dexamethasone

Day 1:

Aprepitant 125 mg PO, 1 hour before chemotherapy Ramosetron 0.6 mg IV, 30 min before chemotherapy Dexamethasone 12 mg PO, 30 min before chemotherapy

Day 2 - 3:

Aprepitant 80 mg PO. in the morning Dexamethasone 8 mg PO. in the morning

Day 4 Dexamethasone 8 mg PO. in the morning

Other Names:
  • Nasea
  • Emend

Detailed Description:

Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis. Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and tolerability and a longer duration of effect than granisetron in preventing acute vomiting in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase emesis was less than 60%.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 -75 years, both sex
  • ECOG performance status 0-2
  • Histologically proven solid cancer, chemotherapy-naïve patient
  • Planed to receive cisplatin (≥ 50mg/m2) based, single day chemotherapy,
  • No nausea or vomiting within 72 hours prior to chemotherapy
  • Serum Cr < 2.5 mg/dl, or calculated CCr ≥ 50 ml/min
  • Serum total bilirubin < 2 mg/dl, AST/ALT < 3 times the upper normal limit , ALP < 5 times the upper normal limit
  • Absolute neutrophil count ≥ 1,500/μL, platelet ≥ 100,000/μL
  • Expected life duration ≥ 3 months
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

  • Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, active gastric or duodenal ulcers, or pregnancy or breast-feeding
  • Patients who should take steroid, antiemetics, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir for the treatment of other diseases
  • Patients taking any medicine, which could affect study results, within 1 week before chemotherapy (or taking anti-emetics within 48 hours before chemotherapy). Prior to beginning chemotherapy, single-agent benzodiazepines as hypnotic is allowed, but it can't be receiving during day 1-6 of 1st chemotherapy cycle.
  • Patients with symptomatic brain metastasis
  • Patients with GI obstruction or other diseases that could provoke nausea and vomiting
  • Patients receiving RT on brain, abdomen or pelvis within 2 weeks before chemotherapy
  • Patients who cannot understand informed consent or express his/her condition
  • Patients who cannot swallow drugs
  • Patients who have known allergy or severe side effect on study drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046461

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, Korea, Republic of, 431-070
Sponsors and Collaborators
Hallym University Medical Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Hyo Jung Kim, M.D. Hallym University Medical Center
  More Information

No publications provided

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01046461     History of Changes
Other Study ID Numbers: RAD1.0
Study First Received: January 8, 2010
Last Updated: February 16, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Hallym University Medical Center:
Ramosetron
aprepitant
dexamethasone
cancer
chemotherapy
antiemetics
cisplatin
nausea
vomiting
high dose cisplatin

Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Aprepitant
BB 1101
Cisplatin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Fosaprepitant
Ramosetron
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 19, 2014