Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
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| ClinicalTrials.gov Identifier: NCT00903396 |
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Recruitment Status :
Terminated
(Slow accrual)
First Posted : May 18, 2009
Results First Posted : February 1, 2017
Last Update Posted : November 24, 2017
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Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
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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 |
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 Type : | Interventional (Clinical Trial) |
| 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 : | September 2009 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | May 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Nausea and Vomiting
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I
Patients receive palonosetron hydrochloride IV on day 1.
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Drug: palonosetron hydrochloride
Given IV |
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Experimental: Arm II
Patients receive palonosetron hydrochloride IV on days 1 and 4.
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Drug: palonosetron hydrochloride
Given IV |
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Placebo Comparator: Arm III
Patients receive placebo IV on day 1.
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Other: placebo
Given IV |
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Placebo Comparator: Arm IV
Patients receive placebo IV on days 1 and 4.
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Other: placebo
Given IV |
Primary Outcome Measures :
- Complete Response (no Episodes of Nausea or Vomiting) [ Time Frame: Up to 2 years ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of primary gastrointestinal and/or retroperitoneal sarcoma
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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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903396
Locations
Show 69 study locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
| Study Chair: | Michele Yvette Halyard, MD | Mayo Clinic |
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00903396 |
| Other Study ID Numbers: |
NCCTG-N08C2 NCI-2009-01109 ( Registry Identifier: CTRP (Clinical Trials Reporting System) ) CDR0000642449 ( Registry Identifier: PDQ (Physician Data Query) ) |
| First Posted: | May 18, 2009 Key Record Dates |
| Results First Posted: | February 1, 2017 |
| Last Update Posted: | November 24, 2017 |
| Last Verified: | October 2017 |
Keywords provided by Alliance for Clinical Trials in Oncology:
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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:
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Pancreatic Neoplasms Stomach Neoplasms Carcinoid Tumor Anus Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms Cholangiocarcinoma Intestinal Neoplasms Nausea Vomiting Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Colorectal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Stomach Diseases Signs and Symptoms, Digestive Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |