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

January 8, 2010
February 16, 2012
January 2010
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01046461 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer
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

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

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%.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Solid Tumour
  • Postoperative Nausea and Vomiting
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
Experimental: Ramosetron, Aprepitant, Dexamethasone
Intervention: Drug: Ramosetron, Aprepitant, Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
41
June 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01046461
RAD1.0
No
Hallym University Medical Center
Hallym University Medical Center
Merck Sharp & Dohme Corp.
Principal Investigator: Hyo Jung Kim, M.D. Hallym University Medical Center
Hallym University Medical Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP