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| ID | Type | Description | Link |
|---|---|---|---|
| OHSU-SOL-06006-LM | Other Identifier | OHSU Knight Cancer Institute | |
| OHSU-IRB-2302 | Other Identifier | OHSU IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy.
PURPOSE: This phase II trial is studying how well giving aprepitant together with palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy in patients receiving chemotherapy for metastatic colorectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Beginning 1 hour prior to the initiation of chemotherapy on day 1, patients receive oral aprepitant on days 1-3, oral dexamethasone on days 1-4, and palonosetron hydrochloride IV on day 1.
Nausea is assessed daily for up to 4 courses of chemotherapy.
Quality of life is assessed at baseline.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant and Palonosetron | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aprepitant | Drug | Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy | Duration of time that the patient is on study | |
| Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population. |
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DISEASE CHARACTERISTICS:
Diagnosis of colorectal cancer
Metastatic disease
Scheduled to receive 1 of the following chemotherapy regimens*:
No emesis and no requirement for antiemetic agents within 48 hours prior to beginning chemotherapy
No chronic nausea
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior chemotherapy > Hesketh level 3
At least 30 days since prior investigational drugs
At least 14 days since prior neurokinin-1 antagonists
Concurrent hydrocortisone at physiologic replacement doses (≤ 30 mg/day) allowed
No concurrent chronic antiemetic agents
Concurrent hypnotics allowed
Concurrent rescue antiemetics allowed
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Bubalo, PharmD, BCPS, BCOP | OHSU Knight Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Josephs/Cander Hospital | Savannah | Georgia | 31405 | United States | ||
| Kaiser Permanente |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aprepitant and Palonosetron | Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle Palonosetron: 0.25 mg IV push on day 1 only |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| dexamethasone | Drug | Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4 |
|
| fluorouracil | Drug | as per institutional standard of care |
|
|
| irinotecan hydrochloride | Drug | as per institutional standard of care |
|
|
| leucovorin calcium | Drug | as per institutional standard of care |
|
|
| oxaliplatin | Drug | as per institutional standard of care |
|
|
| palonosetron hydrochloride | Drug | Palonosetron 0.25 mg IV push on day 1 only. |
|
|
| quality-of-life assessment | Procedure | baseline |
|
| Duration of time the patient is on study |
| To Assess the Safety of the Combination of Aprepitant, Palonosetron, and Dexamethasone in the Colorectal Cancer(CRC) Population in the First and Subsequent Cycles of Chemotherapy. | Duration of time patient is on study |
| Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy | within 5 days of chemotherapy |
| Hilo |
| Hawaii |
| 86720 |
| United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Kansas City Cancer Center | Kansas City | Missouri | 64104 | United States |
| OHSU Knight Cancer Institute | Portland | Oregon | 97239-3098 | United States |
| Texas A & M university / Scott and White Clinic | Temple | Texas | 76508 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aprepitant and Palonosetron | Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle Palonosetron: 0.25 mg IV push on day 1 only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy. | Posted | Number | Participants | Up to 24 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy | Not Posted | Duration of time that the patient is on study | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population. | Not Posted | Duration of time the patient is on study | Participants | ||||||||||||||||||||||||||||||||
| Secondary | To Assess the Safety of the Combination of Aprepitant, Palonosetron, and Dexamethasone in the Colorectal Cancer(CRC) Population in the First and Subsequent Cycles of Chemotherapy. | Not Posted | Duration of time patient is on study | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy | Not Posted | within 5 days of chemotherapy | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aprepitant and Palonosetron | Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle Palonosetron: 0.25 mg IV push on day 1 only | 29 | 54 | 18 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders |
| |||
| Anemia | Blood and lymphatic system disorders |
| |||
| Bowel Obstruction | Gastrointestinal disorders |
| |||
| Compression Fracture | Musculoskeletal and connective tissue disorders |
| |||
| Decreased Mental Status | Psychiatric disorders |
| |||
| Dehydration | General disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Diverticulitis | Gastrointestinal disorders |
| |||
| Dizziness | General disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Fall | Injury, poisoning and procedural complications |
| |||
| GI Perforation | Gastrointestinal disorders |
| |||
| Hyperglycemia | Blood and lymphatic system disorders |
| |||
| Hypokalemia | Blood and lymphatic system disorders |
| |||
| Infections | Infections and infestations |
| |||
| Melena | Gastrointestinal disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Syncope | Vascular disorders |
| |||
| Transient Ischemic Attack (TIA) | Vascular disorders |
| |||
| Venous Thromboembolism (VTE) | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders |
| |||
| Heartburn/ Gastroesophageal Reflux Disease (GERD) | Gastrointestinal disorders |
| |||
| Neuropathy-Cold Related | Nervous system disorders |
| |||
| Neuropathy-Peripheral/Sensory | Nervous system disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Bubalo, PharmD, BCPS, BCOP | OHSU Knight Cancer Institute | 503-494-1080 | bubaloj@ohsu.edu |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009325 | Nausea |
| D014839 | Vomiting |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| C400262 | L 758298 |
| D003907 | Dexamethasone |
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D000077924 | Palonosetron |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D007546 | Isoquinolines |
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