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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Solid Tumour, Postoperative Nausea and Vomiting

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Trial Information

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%.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

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)

Outcome Time Frame:

from chemotherapy day 1 to day 5

Safety Issue:

No

Principal Investigator

Hyo Jung Kim, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hallym University Medical Center

Authority:

Korea: Institutional Review Board

Study ID:

RAD1.0

NCT ID:

NCT01046461

Start Date:

January 2010

Completion Date:

June 2012

Related Keywords:

  • Solid Tumour
  • Postoperative Nausea and Vomiting
  • Ramosetron
  • aprepitant
  • dexamethasone
  • cancer
  • chemotherapy
  • antiemetics
  • cisplatin
  • nausea
  • vomiting
  • high dose cisplatin
  • Nausea
  • Vomiting
  • Postoperative Nausea and Vomiting

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