Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer
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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 |
- 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 ]
- 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:
|
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 |
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| Korea, Republic of | |
| Hallym University Sacred Heart Hospital | |
| Anyang-si, Gyeonggi-do, Korea, Republic of, 431-070 | |
| 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 Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Cisplatin Dexamethasone Dexamethasone acetate Ramosetron Aprepitant Dexamethasone 21-phosphate BB 1101 Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Protease Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013