Anal CancerPhase 2NCT00903396
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
A Phase 2 study testing palonosetron hydrochloride in people with Anal Cancer and Carcinoma of the Appendix, run by Alliance for Clinical Trials in Oncology at 69 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer, Carcinoma of the Appendix, Colorectal Cancer
- What is being tested?
- palonosetron hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 69 sitesUnited States
- Study dates
- Sep 2009to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
Study site
Bettendorf, Iowa, 52722
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59102
Billings Clinic - Downtown
Billings, Montana, 59107-7000
Bismarck Cancer Center
Bismarck, North Dakota, 58501
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, 58502
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715
St. James Healthcare Cancer Care
Butte, Montana, 59701
Rocky Mountain Oncology
Casper, Wyoming, 82609
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, 55805-1983
CCOP - Duluth
Duluth, Minnesota, 55805
Miller - Dwan Medical Center
Duluth, Minnesota, 55805
Elkhart Clinic, LLC
Elkhart, Indiana, 46514-2098
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, 46514
Elkhart General Hospital
Elkhart, Indiana, 46515
Fergus Falls Medical Group, PA
Fergus Falls, Minnesota, 56537
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, 58201
Big Sky Oncology
Great Falls, Montana, 59405-5309
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508
Northern Montana Hospital
Havre, Montana, 59501
St. Peter's Hospital
Helena, Montana, 59601
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Glacier Oncology, PLLC
Kalispell, Montana, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901
Kalispell Regional Medical Center
Kalispell, Montana, 59901
Howard Community Hospital
Kokomo, Indiana, 46904
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, 54601
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, 54221-1450
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, 46545-1470
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, 61265
Study site
Moline, Illinois, 61265
Michiana Hematology Oncology PC - Niles
Niles, Michigan, 49120
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
Creighton University Medical Center
Omaha, Nebraska, 68131-2197
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, 46563
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, 49085
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, 82801
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Memorial Hospital of South Bend
South Bend, Indiana, 46601
South Bend Clinic
South Bend, Indiana, 46617
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802
St. John's Regional Health Center
Springfield, Missouri, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay, Wisconsin, 54235-1495
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, 46391
Wesley Medical Center
Wichita, Kansas, 67214
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
About this study
Official title: A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting
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.
Read the 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.
- Conditions
- Anal Cancer, Carcinoma of the Appendix, Colorectal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer
- Being tested
- palonosetron hydrochloride, placebo
- Keywords
- 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
- Medical subject headings
- Anus Neoplasms, Appendiceal Neoplasms, Colorectal Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms, Stomach Neoplasms, Liver Neoplasms, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palonosetron hydrochlorideDrug
Given IV
placeboOther
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive palonosetron hydrochloride IV on day 1. Receives: Drug: palonosetron hydrochloride |
| Arm II | Experimental | Patients receive palonosetron hydrochloride IV on days 1 and 4. Receives: Drug: palonosetron hydrochloride |
| Arm III | Placebo comparator | Patients receive placebo IV on day 1. Receives: Other: placebo |
| Arm IV | Placebo comparator | Patients receive placebo IV on days 1 and 4. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (no Episodes of Nausea or Vomiting)
Measured: Up to 2 years
Secondary outcomes (4)
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
Measured: Up to 2 years
Proportion of Patients Reporting Treatment Failure
Measured: Up to 2 years
Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
Measured: Up to 2 years
Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionMay 2013
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michele Yvette Halyard, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903396
- Sponsor's protocol ID
- NCCTG-N08C2
- Other IDs
- NCI-2009-01109, CDR0000642449
- Status last verified
- Oct 2017
- First submitted
- 15 May 2009
- Last updated
- 24 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT00903396
- Acronym / sponsor ID
- NCCTG-N08C2
- Conditions
- Anal Cancer, Carcinoma of the Appendix, Colorectal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer
- Keywords
- nausea and vomiting, gastrointestinal carcinoid tumor, anal cancer, carcinoma of the appendix, colon cancer, rectal cancer, extrahepatic bile duct cancer, gallbladder cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2009 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 18 May 2009 (estimated)
- Results
- Posted 1 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: palonosetron hydrochloridePatients receive palonosetron hydrochloride IV on day 1. |
| Arm II | Experimental | Drug: palonosetron hydrochloridePatients receive palonosetron hydrochloride IV on days 1 and 4. |
| Arm III | Placebo comparator | Other: placeboPatients receive placebo IV on day 1. |
| Arm IV | Placebo comparator | Other: placeboPatients receive placebo IV on days 1 and 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| palonosetron hydrochlorideGiven IV | Drug | Arm I, Arm II |
| placeboGiven IV | Other | Arm III, Arm IV |
Primary outcome
Complete Response (no Episodes of Nausea or Vomiting)
Time frame: Up to 2 years
4 secondary outcomes
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
Proportion of Patients Reporting Treatment Failure
Time frame: Up to 2 years
Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
Time frame: Up to 2 years
Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Yvette Halyard, MD study chair
Mayo Clinic
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing palonosetron hydrochloride in people with Anal Cancer and Carcinoma of the Appendix, run by Alliance for Clinical Trials in Oncology at 69 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (no Episodes of Nausea or Vomiting) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.