Know Cancer

or
forgot password

Phase II Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Chemotherapy-Induced Nausea and Vomiting, Non Hodgkin's Lymphoma

Thank you

Trial Information

Phase II Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy


Inclusion Criteria:



- Male or female, >18 years of age;

- Histologically or cytologically confirmed aggressive NHL (any stage in accordance
with the REAL Classification);

- Patients candidates to a initial chemotherapy treatment;

- ECOG performance status of 0-1;

- Scheduled to receive a single intravenous dose of at least one of the moderately
emetogenic agents (according to the modified Hesketh classification) on Day 1;

- Written informed consent;

- Female of childbearing potential must be using reliable contraceptive measures;

- Acceptable hepatic and renal functions;

- Willing and able to complete the patient diary.

Exclusion Criteria:

- Highly emetogenic chemotherapy (containing cisplatin, mechlorethamine,
streptozotocin, cyclophosphamide >1500 mg/sqm; carmustine; dacarbazine;
hexamethylmelamine; procarbazine), or single-agent chemotherapy with drugs having
low/minimal emetogenic potential according to the Hesketh classification);

- Diagnosis of Hodgkin's Disease or Leukemia;

- Candidates to High-Dose Chemotherapy or Bone Marrow/Peripheral Blood Stem Cells
Transplantation;

- Chemotherapy schedules considering the administration of emetogenic drugs in more
than two consecutive days;

- Have received any investigational drugs within 30 days before study entry;

- Have received any drug with potential anti-emetic efficacy (with the exception of
specific corticosteroids foreseen in the chemotherapy combination) within 24 hours of
treatment initiation);

- Prior treatment with Palonosetron;

- Have a seizure disorder requiring anticonvulsant medication unless clinically stable
and free of seizure activity;

- Experienced or ongoing vomiting or nausea from any organic etiology, in the screening
phase;

- Clinical evidence of current or impending bowel obstruction, peritonitis, infection,
uremia, severe mucositis;

- Clinically relevant electrolyte abnormalities;

- Have a known hypersensitivity to 5HT3 receptor antagonists;

- Radiotherapy within 30 days before chemotherapy administration, or scheduled to
receive radiotherapy within two weeks after chemotherapy;

- Female patients who are pregnant or breast feeding;

- Inability to understand or cooperate with the study procedures.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)

Outcome Time Frame:

0-120 hours

Safety Issue:

No

Principal Investigator

Nicola Di Renzo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gruppo Italiano Studio Linfomi

Authority:

Italy: Ethics Committee

Study ID:

NHLPal

NCT ID:

NCT01018758

Start Date:

July 2006

Completion Date:

July 2008

Related Keywords:

  • Chemotherapy-Induced Nausea and Vomiting
  • Non Hodgkin's Lymphoma
  • Non-Hodgkin's lymphoma
  • Quality of life
  • Chemotherapy toxicity
  • aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy
  • Aggression
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Nausea
  • Vomiting

Name

Location