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A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Anal Cancer, Carcinoma of the Appendix, Colorectal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer, Gastrointestinal Carcinoid Tumor, Liver Cancer, Nausea and Vomiting, Pancreatic Cancer, Primary Peritoneal Cavity Cancer, Small Intestine Cancer

Thank you

Trial Information

A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting


OBJECTIVES:

- Evaluate the rate of complete responses, defined as no vomiting and no nausea, in
patients with primary gastrointestinal and/or retroperitoneal sarcomas treated with two
different dosing schedules of palonosetron hydrochloride during abdominal radiotherapy
as part of their cancer treatment.

- Determine the tolerability of palonosetron hydrochloride vs placebo in these patients.

- Validate patient diaries for assessing nausea and vomiting by comparing with
alternative methods for measuring nausea and vomiting in order to determine the optimal
approach for future studies.

OUTLINE: Patients are stratified according to planned radiotherapy duration (< 5 weeks vs ≥
5 weeks), planned concurrent fluorouracil ( yes vs no), and gender. Patients are randomized
to 1 of 4 treatment arms.

- Arm I: Patients receive palonosetron hydrochloride IV on day 1.

- Arm II: Patients receive palonosetron hydrochloride IV on days 1 and 4.

- Arm III: Patients receive placebo IV on day 1.

- Arm IV: Patients receive placebo IV on days 1 and 4. In all arms, courses repeat weekly
during radiotherapy in the absence of disease progression or unacceptable toxicity.

Patients complete nausea and vomiting questionnaires and diaries at baseline and daily
during radiotherapy. Patients also complete symptom experience diaries weekly during
radiotherapy.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of primary gastrointestinal and/or retroperitoneal sarcoma

- Scheduled to undergo ≥ 3000 cGy or ≥ 3 weeks of external beam radiation to the
abdomen

- Radiotherapy fields to extend between T11 and L3, and of a size ≥ 100 cm^2

- No brain metastases

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Able to complete questionnaire(s) alone or with assistance

- Willing to return to NCCTG enrolling institution for follow-up

- Able to reliably take oral medication (for purposes of rescue medication)

- No hypersensitivity to palonosetron hydrochloride or other selective 5-HT3 receptor
antagonists

- No comorbid systemic illness or other severe concurrent disease that, in the judgment
of the investigator, would make the patient inappropriate for study entry or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens

- No nausea ≤ 48 hours prior to study enrollment

- No history of dystonic reactions to prochlorperazine or haloperidol or related agents

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 7 days since prior agents known to have significant effects on emesis,
including the following:

- Ondansetron

- Sedating antihistamines

- Antipsychotics

- Cannabinoids

- Corticosteroids

- Metoclopramide

- Narcotic analgesics

- Benzodiazepines

- More than 7 days since prior chemotherapy other than fluorouracil or capecitabine
used as a radiosensitizer

- More than 7 days since of prior cetuximab

- More than 7 days since prior and no concurrent oral steroids

- No prior palonosetron hydrochloride

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Complete response (no episodes of nausea or vomiting)

Safety Issue:

No

Principal Investigator

Michele Yvette Halyard, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000642449

NCT ID:

NCT00903396

Start Date:

September 2009

Completion Date:

Related Keywords:

  • Anal Cancer
  • Carcinoma of the Appendix
  • Colorectal Cancer
  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Gastric Cancer
  • Gastrointestinal Carcinoid Tumor
  • Liver Cancer
  • Nausea and Vomiting
  • Pancreatic Cancer
  • Primary Peritoneal Cavity Cancer
  • Small Intestine Cancer
  • nausea and vomiting
  • gastrointestinal carcinoid tumor
  • anal cancer
  • carcinoma of the appendix
  • colon cancer
  • rectal cancer
  • extrahepatic bile duct cancer
  • gallbladder cancer
  • gastric cancer
  • liver and intrahepatic biliary tract cancer
  • pancreatic cancer
  • small intestine cancer
  • primary peritoneal cavity cancer
  • Anus Neoplasms
  • Carcinoid Tumor
  • Carcinoma
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Stomach Neoplasms
  • Nausea
  • Vomiting
  • Pancreatic Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Peritoneal Neoplasms
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Intestinal Neoplasms
  • Colonic Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Rapid City Regional HospitalRapid City, South Dakota  57709
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Wesley Medical CenterWichita, Kansas  67214
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
South Bend ClinicSouth Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Bettendorf, Iowa  52722
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Bismarck Cancer CenterBismarck, North Dakota  58501
Holy Family Memorial Medical Center Cancer Care CenterManitowoc, Wisconsin  54221-1450
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Michiana Hematology Oncology PC - NilesNiles, Michigan  49120
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Fergus Falls Medical Group, PAFergus Falls, Minnesota  56537
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Rocky Mountain OncologyCasper, Wyoming  82609
Mid Dakota Clinic, PCBismarck, North Dakota  58501
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
Franciscan Skemp Healthcare - La Crosse CampusLa Crosse, Wisconsin  54601
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Door County Cancer Center at Door County Memorial HospitalSturgeon Bay, Wisconsin  54235-1495