Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00903396
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 7
• Locations: 69
• Arms: 4
• Actual Duration (Months): 44
• Patients Per Site: 0.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Palonosetron hydrochloride may prevent nausea and vomiting caused by radiation therapy. It is not yet known whether palonosetron hydrochloride is more effective than a placebo in preventing nausea and vomiting.

PURPOSE: This randomized phase II trial is studying the side effects of palonosetron hydrochloride and to see how well it works in preventing nausea and vomiting caused by radiation therapy in patients with primary abdominal cancer.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: palonosetron hydrochloride; Other: placebo	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting
• Actual Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive palonosetron hydrochloride IV on day 1.	Drug: palonosetron hydrochloride; Given IV
Experimental: Arm II Patients receive palonosetron hydrochloride IV on days 1 and 4.	Drug: palonosetron hydrochloride; Given IV
Placebo Comparator: Arm III Patients receive placebo IV on day 1.	Other: placebo; Given IV
Placebo Comparator: Arm IV Patients receive placebo IV on days 1 and 4.	Other: placebo; Given IV

Outcome Measures

Primary Outcome Measures

1. Complete Response (no Episodes of Nausea or Vomiting) [Up to 2 years]

Secondary Outcome Measures

1. Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day [Up to 2 years]

2. Proportion of Patients Reporting Treatment Failure [Up to 2 years]

3. Tolerability and Adverse Events as Assessed by NCI CTC v 3.0 [Up to 2 years]

4. Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm [Up to 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259-5499
2	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
3	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois	United States	61265
4		Moline	Illinois	United States	61265
5	Elkhart Clinic, LLC	Elkhart	Indiana	United States	46514-2098
6	Michiana Hematology-Oncology, PC - Elkhart	Elkhart	Indiana	United States	46514
7	Elkhart General Hospital	Elkhart	Indiana	United States	46515
8	Howard Community Hospital	Kokomo	Indiana	United States	46904
9	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
10	Michiana Hematology-Oncology, PC - South Bend	Mishawaka	Indiana	United States	46545-1470
11	Saint Joseph Regional Medical Center	Mishawaka	Indiana	United States	46545-1470
12	Michiana Hematology Oncology PC - Plymouth	Plymouth	Indiana	United States	46563
13	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
14	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
15	South Bend Clinic	South Bend	Indiana	United States	46617
16	Michiana Hematology Oncology PC - La Porte	Westville	Indiana	United States	46391
17		Bettendorf	Iowa	United States	52722
18	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
19	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
20	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
21	Wesley Medical Center	Wichita	Kansas	United States	67214
22	Michiana Hematology Oncology PC - Niles	Niles	Michigan	United States	49120
23	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan	United States	49085
24	Lakeside Cancer Specialists, PLLC	Saint Joseph	Michigan	United States	49085
25	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
26	CCOP - Duluth	Duluth	Minnesota	United States	55805
27	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
28	Fergus Falls Medical Group, PA	Fergus Falls	Minnesota	United States	56537
29	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
30	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
31	St. John's Regional Health Center	Springfield	Missouri	United States	65804
32	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
33	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
34	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
35	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
36	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
37	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
38	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
39	Big Sky Oncology	Great Falls	Montana	United States	59405-5309
40	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
41	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
42	Northern Montana Hospital	Havre	Montana	United States	59501
43	St. Peter's Hospital	Helena	Montana	United States	59601
44	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
45	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
46	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
47	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
48	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
49	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
50	Creighton University Medical Center	Omaha	Nebraska	United States	68131-2197
51	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
52	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota	United States	58501
53	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
54	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota	United States	58502
55	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota	United States	58201
56	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania	United States	17822-0001
57	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
58	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
59	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54301-3526
60	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
61	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
62	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
63	Franciscan Skemp Healthcare - La Crosse Campus	La Crosse	Wisconsin	United States	54601
64	Holy Family Memorial Medical Center Cancer Care Center	Manitowoc	Wisconsin	United States	54221-1450
65	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
66	Door County Cancer Center at Door County Memorial Hospital	Sturgeon Bay	Wisconsin	United States	54235-1495
67	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
68	Rocky Mountain Oncology	Casper	Wyoming	United States	82609
69	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Michele Yvette Halyard, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00903396
• Other Study ID Numbers: NCCTG-N08C2; NCI-2009-01109; CDR0000642449
• First Posted: May 18, 2009
• Last Update Posted: Nov 24, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Alliance for Clinical Trials in Oncology: 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
• Additional relevant MeSH terms: Pancreatic Neoplasms; Stomach Neoplasms; Carcinoid Tumor; Anus Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma; Intestinal Neoplasms; Nausea; Vomiting; Palonosetron

Study Results

Participant Flow

Arm/Group Title	Arm I	Arm II	Arm III	Arm IV
Arm/Group Description	Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV	Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV	Patients receive placebo IV on day 1. placebo: Given IV	Patients receive placebo IV on days 1 and 4. placebo: Given IV
Period Title: Overall Study
STARTED	2	1	3	1
COMPLETED	2	1	3	1
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Arm I	Arm II	Arm III	Arm IV	Total
Arm/Group Description	Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV	Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV	Patients receive placebo IV on day 1. placebo: Given IV	Patients receive placebo IV on days 1 and 4. placebo: Given IV	Total of all reporting groups
Overall Participants	0	0	0	0	0
Age () []
Sex: Female, Male () []
Female
Male

Outcome Measures

1. Primary Outcome

Title	Complete Response (no Episodes of Nausea or Vomiting)
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.

Arm/Group Title	Arm I	Arm II	Arm III	Arm IV
Arm/Group Description	Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV	Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV	Patients receive placebo IV on day 1. placebo: Given IV	Patients receive placebo IV on days 1 and 4. placebo: Given IV
Measure Participants	0	0	0	0

2. Secondary Outcome

Title	Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.

Arm/Group Title	Arm I	Arm II	Arm III	Arm IV
Arm/Group Description	Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV	Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV	Patients receive placebo IV on day 1. placebo: Given IV	Patients receive placebo IV on days 1 and 4. placebo: Given IV
Measure Participants	0	0	0	0

3. Secondary Outcome

Title	Proportion of Patients Reporting Treatment Failure
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.

Arm/Group Title	Arm I	Arm II	Arm III	Arm IV
Arm/Group Description	Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV	Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV	Patients receive placebo IV on day 1. placebo: Given IV	Patients receive placebo IV on days 1 and 4. placebo: Given IV
Measure Participants	0	0	0	0

4. Secondary Outcome

Title	Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.

Arm/Group Title	Arm I	Arm II	Arm III	Arm IV
Arm/Group Description	Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV	Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV	Patients receive placebo IV on day 1. placebo: Given IV	Patients receive placebo IV on days 1 and 4. placebo: Given IV
Measure Participants	0	0	0	0

5. Secondary Outcome

Title	Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.

Arm/Group Title	Arm I	Arm II	Arm III	Arm IV
Arm/Group Description	Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV	Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV	Patients receive placebo IV on day 1. placebo: Given IV	Patients receive placebo IV on days 1 and 4. placebo: Given IV
Measure Participants	0	0	0	0

Adverse Events

Adverse Event Reporting Description	Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Arm/Group Title	Arm I		Arm II		Arm III		Arm IV
Arm/Group Description	Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV		Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV		Patients receive placebo IV on day 1. placebo: Given IV		Patients receive placebo IV on days 1 and 4. placebo: Given IV
All Cause Mortality
	Arm I		Arm II		Arm III		Arm IV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I		Arm II		Arm III		Arm IV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Arm I		Arm II		Arm III		Arm IV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.