Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | October 15, 2018 |
End Date: | March 2020 |
Contact: | Rudolph Navari, MD, PhD, FACP |
Email: | rnavari@uabmc.edu |
Phone: | 205-975-2833 |
Olanzapine With or Without Fosaprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Phase III Randomized, Double Blind, Placebo-Controlled Trial
This randomized phase III trial studies how well olanzapine with or without fosaprepitant
work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving
chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control
nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in
combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if
olanzapine when given with other drugs, is still effective without using fosaprepitant
dimeglumine for controlling nausea and vomiting.
work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving
chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control
nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in
combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if
olanzapine when given with other drugs, is still effective without using fosaprepitant
dimeglumine for controlling nausea and vomiting.
PRIMARY OBJECTIVES:
I. To compare between the two study arms the proportion of patients with no nausea for the
overall (0-120 hours post-chemotherapy), acute (0-24 hours post-chemotherapy), and delayed
periods (24-120 hours post-chemotherapy) for patients receiving highly emetogenic
chemotherapy (HEC).
SECONDARY OBJECTIVES:
I. To compare between the two study arms the complete response (CR) rates (no emetic episodes
and no use of rescue medication) in the acute, delayed, and overall periods.
II. To compare between the two study arms, the incidences of potential toxicities that have
been ascribed to olanzapine.
III. To perform an economic evaluation of olanzapine and fosaprepitant dimeglumine
(fosaprepitant) versus (vs.) olanzapine in patients receiving HEC (noting that all patients
will also receive dexamethasone and a 5HT3 receptor antagonist).
IV. To explore the efficacy of olanzapine in chemotherapy cycles two to four, for patients
who elect to continue on the same antiemetic regimen received in cycle one, in chemotherapy
cycles two to four (continuation phase), by documenting nausea and complete response.
V. To explore the safety of olanzapine in chemotherapy cycles two to four, for patients who
elect to continue on the same antiemetic regimen received in cycle one, in chemotherapy
cycles two to four (continuation phase), by recording any adverse events or drug related
toxicities.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive palonosetron hydrochloride intravenously (IV) over 30 seconds or
ondansetron hydrochloride IV over 2-5 minutes or orally (PO) on day 1, dexamethasone PO on
days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days
1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
ARM II: Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron
hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV
over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may
repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study, patients are followed up periodically.
I. To compare between the two study arms the proportion of patients with no nausea for the
overall (0-120 hours post-chemotherapy), acute (0-24 hours post-chemotherapy), and delayed
periods (24-120 hours post-chemotherapy) for patients receiving highly emetogenic
chemotherapy (HEC).
SECONDARY OBJECTIVES:
I. To compare between the two study arms the complete response (CR) rates (no emetic episodes
and no use of rescue medication) in the acute, delayed, and overall periods.
II. To compare between the two study arms, the incidences of potential toxicities that have
been ascribed to olanzapine.
III. To perform an economic evaluation of olanzapine and fosaprepitant dimeglumine
(fosaprepitant) versus (vs.) olanzapine in patients receiving HEC (noting that all patients
will also receive dexamethasone and a 5HT3 receptor antagonist).
IV. To explore the efficacy of olanzapine in chemotherapy cycles two to four, for patients
who elect to continue on the same antiemetic regimen received in cycle one, in chemotherapy
cycles two to four (continuation phase), by documenting nausea and complete response.
V. To explore the safety of olanzapine in chemotherapy cycles two to four, for patients who
elect to continue on the same antiemetic regimen received in cycle one, in chemotherapy
cycles two to four (continuation phase), by recording any adverse events or drug related
toxicities.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive palonosetron hydrochloride intravenously (IV) over 30 seconds or
ondansetron hydrochloride IV over 2-5 minutes or orally (PO) on day 1, dexamethasone PO on
days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days
1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
ARM II: Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron
hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV
over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may
repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study, patients are followed up periodically.
Inclusion Criteria:
- Diagnosis of malignant disease of any stage; (stage I through stage IV)
- No prior history of chemotherapy for any malignancy
- Scheduled to receive HEC (highly emetogenic chemotherapy) (either cisplatin-containing
regimen or doxorubicin and cyclophosphamide [AC]); cisplatin, given on a single day,
at a dose of >= 70 mg/m^2, with or without other chemotherapy agent(s) OR doxorubicin
(60 mg/m^2) plus cyclophosphamide (600 mg/m^2)
- No nausea or vomiting =< 24 hours prior to registration
- Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for
women of childbearing potential only
* A female of childbearing potential is a sexually mature female who: 1) has not
undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in
the preceding 12 consecutive months)
- No known diagnosis of dementia; patients with stable treated brain metastases are
eligible to participate
- No known history of central nervous system (CNS) disease (e.g. seizure disorder)
- No treatment with another antipsychotic agent such as risperidone, quetiapine,
clozapine, phenothiazine or butyrophenone =< 30 days prior to registration
- No chronic phenothiazine administration as an antipsychotic agent (patients may
receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy)
- No use of amifostine within 7 days prior to registration
- No radiotherapy within 7 days prior to registration or planned for one week after the
current dose of chemotherapy
- No use of quinolone antibiotic therapy within 7 days prior to registration
- No chronic alcoholism (as determined by the investigator)
- No known hypersensitivity to olanzapine
- No known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial
infarction within the previous six months
- No history of uncontrolled diabetes mellitus, i.e., no diabetic ketoacidosis; within 6
months prior to registration; patients are eligible if they have controlled diabetes
on diet, oral agents, and/or insulin
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Patients must be able to read and comprehend English
- Serum creatinine =< 2.0 mg/dL =< 120 days prior to registration
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x upper limit
of normal (ULN) =< 120 days prior to registration
We found this trial at
386
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Canton, Michigan 48188
Canton, Michigan 48188
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
573-331-3000
![Saint Francis Medical Center](/wp-content/uploads/logos/saint-francis-medical-center.png)
Principal Investigator: Bryan A. Faller
Phone: 573-334-2230
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
(573) 519-4725
![Southeast Cancer Center](/wp-content/uploads/logos/southeast-cancer-center.png)
Principal Investigator: Bryan A. Faller
Phone: 573-651-5550
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Carbondale, Illinois 62902
Principal Investigator: Bryan A. Faller
Phone: 618-457-5200
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401 North Hooper Street
Caro, Michigan 48723
Caro, Michigan 48723
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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Carterville, Illinois 62918
Principal Investigator: Bryan A. Faller
Phone: 618-985-3333
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160 S Adams St
Carthage, Illinois 62321
Carthage, Illinois 62321
(217) 357-6877
![Illinois CancerCare - Carthage](/wp-content/uploads/logos/illinois-cancercare---carthage.jpg)
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W. Wilbur
Phone: 319-365-4673
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Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W. Wilbur
Phone: 319-363-2690
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Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Centralia, Illinois 62801
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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14650 East Old US Highway 12
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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775 South Main Street
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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232 S Woods Mill Rd
Chesterfield, Missouri 63017
Chesterfield, Missouri 63017
(314) 205-6491
![Saint Luke's Hospital](/wp-content/uploads/logos/saint-luke-s-hospital.gif)
Principal Investigator: Donald F. Busiek
Phone: 773-702-9171
Saint Luke's Hospital St. Luke's Hospital, located in Chesterfield, Missouri, is a regional healthcare provider...
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Cheyenne, Wyoming 82001
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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12961 27th Ave
Chippewa Falls, Wisconsin 54729
Chippewa Falls, Wisconsin 54729
715-738-3700
![Marshfield Clinic - Chippewa Center](/wp-content/uploads/logos/marshfield-clinic---chippewa-center.jpg)
Principal Investigator: Demet Gokalp Yasar
Phone: 800-782-8581
Marshfield Clinic - Chippewa Center The 15,000 square foot Lake Hallie Center provides urgent care...
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Cincinnati, Ohio 45236
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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5680 Bow Pointe Drive
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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31500 Telegraph Road
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Principal Investigator: Elie G. Dib
Phone: 734-712-3671
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Clinton, South Carolina 29325
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
(763) 236-6000
![Mercy Hospital](/wp-content/uploads/logos/mercy-hospital.png)
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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1203 South Tyler Street
Covington, Louisiana 70433
Covington, Louisiana 70433
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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Danville, Illinois 61832
Principal Investigator: Maria T. Grosse-Perdekamp
Phone: 800-446-5532
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100 North Academy Avenue
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
![Geisinger Medical Center](/wp-content/uploads/logos/geisinger-medical-center.jpg)
Principal Investigator: Srilatha B. Hosur
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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2222 Philadelphia Dr
Dayton, Ohio 45406
Dayton, Ohio 45406
(937) 734-2612
![Good Samaritan Hospital - Dayton](/wp-content/uploads/logos/good-samaritan-hospital---dayton.png)
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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1 Wyoming St,
Dayton, Ohio 45409
Dayton, Ohio 45409
(937) 208-8000
![Miami Valley Hospital](/wp-content/uploads/logos/miami-valley-hospital.png)
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Dayton, Ohio 45415
Principal Investigator: Howard M. Gross
Phone: 937-832-1093
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Dayton, Ohio 45415
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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210 West McKinley Avenue
Decatur, Illinois 62526
Decatur, Illinois 62526
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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2300 N Edward St
Decatur, Illinois 62526
Decatur, Illinois 62526
(217) 876-8121
![Decatur Memorial Hospital](/wp-content/uploads/logos/decatur-memorial-hospital.jpg)
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Denver, Colorado 80206
Principal Investigator: Keren Sturtz
Phone: 877-225-5654
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3773 Chry Crk North Dr # 101
Denver, Colorado 80209
Denver, Colorado 80209
Principal Investigator: Keren Sturtz
Phone: 773-702-9171
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Denver, Colorado 80218
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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777 Bannock St
Denver, Colorado 80204
Denver, Colorado 80204
(303) 436-6000
![Denver Health Medical Center](/wp-content/uploads/logos/denver-health-medical-center.jpg)
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
![Colorado Blood Cancer Institute](/wp-content/uploads/logos/colorado-blood-cancer-institute.png)
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Denver, Colorado 80218
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Denver, Colorado 80218
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Denver, Colorado 80220
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Denver, Colorado 80220
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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4567 E 9th Ave
Denver, Colorado 80220
Denver, Colorado 80220
(303) 320-2121
![Rose Medical Center](/wp-content/uploads/logos/rose-medical-center.jpg)
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
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Des Moines, Iowa 50309
Principal Investigator: Robert J. Behrens
Phone: 515-282-2921
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Des Moines, Iowa 50314
Principal Investigator: Robert J. Behrens
Phone: 515-282-2200
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