Colorectal CancerPhase 2NCT00381862
Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX
A Phase 2 study testing aprepitant, dexamethasone and fluorouracil in people with Colorectal Cancer and Nausea and Vomiting, run by OHSU Knight Cancer Institute at 6 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer, Nausea and Vomiting
- What is being tested?
- aprepitant, dexamethasone and fluorouracil
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2006to Jul 2008
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of colorectal cancer
- Metastatic disease
- Scheduled to receive 1 of the following chemotherapy regimens*:
- FOLFOX 4 (oxaliplatin, fluorouracil, leucovorin calcium)
- FOLFOX 6
- FOLFOX 7
- FOLFIRI (irinotecan hydrochloride, fluorouracil, leucovorin calcium) NOTE: *Regimens may also include cetuximab or bevacizumab
- No emesis and no requirement for antiemetic agents within 48 hours prior to beginning chemotherapy
- Single-agent benzodiazepines as a hypnotic allowed
- No chronic nausea
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy > 4 months
- White Blood Cell(WBC)count > 3,000/mm^³
- Absolute neutrophil count (ANC) > 1,500/mm^³
- Platelet count > 100,000/mm^³
- Bilirubin ≤ 2.5 times upper limit of normal (ULN) (< 5 times ULN if liver metastases present)
- Creatinine ≤ 1.5 times ULN
- Aspartate aminotransferase(AST) or Alanine aminotransferase (ALT) ≤ 2.5 times ULN (< 5 times ULN if liver metastases present)
- Able to swallow tablets and capsules
- No known sensitivity to aprepitant, palonosetron hydrochloride, or dexamethasone
- Not pregnant or nursing
- Negative pregnancy test
- No history of consuming ≥ 5 alcoholic drinks/day within the past year
- No concurrent illness requiring systemic corticosteroids other than planned dexamethasone during study treatment
- No clinical signs of active systemic infection involving the gastrointestinal tract
- No active bowel obstruction
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy > Hesketh level 3
- Prior fluorouracil with or without leucovorin calcium or capecitabine allowed
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Kaiser Permanente
Hilo, Hawaii, 86720
Kansas City Cancer Center
Kansas City, Missouri, 64104
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098
St. Josephs/Cander Hospital
Savannah, Georgia, 31405
Texas A & M university / Scott and White Clinic
Temple, Texas, 76508
About this study
Official title: A Multi-Center, Trial to Evaluate the Efficacy & Tolerability of Aprepitant and Palonosetron for the Prevention of CINV in Colorectal Cancer (CRC) Patients Receiving FOLFOX
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.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy, in terms of nausea and vomiting control, of aprepitant, palonosetron hydrochloride, and dexamethasone, in preventing chemotherapy-induced nausea and vomiting in patients receiving FOLFOX or FOLFIRI chemotherapy for metastatic colorectal cancer.
Secondary
- Assess the percentage of patients with no emesis and no rescue therapy when treated with aprepitant, palonosetron hydrochloride, and dexamethasone during repeated courses of FOLFOX or FOLFIRI chemotherapy.
- Assess the effects of aprepitant on nausea, appetite, taste changes (via visual analogue scale), nutritional intake, and mucositis in these patients.
- Assess the safety of this regimen in these patients.
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.
- Conditions
- Colorectal Cancer, Nausea and Vomiting
- Being tested
- aprepitant, dexamethasone, fluorouracil, irinotecan hydrochloride, leucovorin calcium
- Keywords
- nausea and vomiting, recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Nausea, Vomiting, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprepitantDrug
Also called Emend, MK-869, L-758,298, L-754,030
Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
dexamethasoneDrug
Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4
fluorouracilDrug
Also called 5-FU
as per institutional standard of care
Also called Trade names: Camptosar®, Other names: Camptothecin-11, CPT-11
as per institutional standard of care
Also called Generic Name: Leucovorin, Other Names: Citrovorum Factor, Folinic Acid
as per institutional standard of care
oxaliplatinDrug
Also called Trade Name: Eloxatin
as per institutional standard of care
palonosetron hydrochlorideDrug
Also called Aloxi
Palonosetron 0.25 mg IV push on day 1 only.
quality-of-life assessmentProcedure or surgery
baseline
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant and Palonosetron | Experimental | Not described Receives: Drug: aprepitant; Drug: dexamethasone; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: oxaliplatin; Drug: palonosetron hydrochloride; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.
Measured: Up to 24 weeks
Secondary outcomes (4)
Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy
Measured: 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.
Measured: 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.
Measured: 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
Measured: within 5 days of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2008
- Study completionJul 2008
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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Joseph Bubalo, OHSU Knight Cancer Institute
- Investigators
- Joseph Bubalo, PharmD, BCPS, BCOP, Study chair, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381862
- Sponsor's protocol ID
- CDR0000503649
- Other IDs
- OHSU-SOL-06006-LM, OHSU-IRB-2302
- Status last verified
- May 2017
- First submitted
- 26 Sep 2006
- Last updated
- 12 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Trial to Evaluate the Efficacy & Tolerability of Aprepitant and Palonosetron for the Prevention of CINV in Colorectal Cancer (CRC) Patients Receiving FOLFOX
- ClinicalTrials.gov ID
- NCT00381862
- Acronym / sponsor ID
- CDR0000503649
- Conditions
- Colorectal Cancer, Nausea and Vomiting
- Keywords
- nausea and vomiting, recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Posted 10 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy, in terms of nausea and vomiting control, of aprepitant, palonosetron hydrochloride, and dexamethasone, in preventing chemotherapy-induced nausea and vomiting in patients receiving FOLFOX or FOLFIRI chemotherapy for metastatic colorectal cancer.
Secondary
- Assess the percentage of patients with no emesis and no rescue therapy when treated with aprepitant, palonosetron hydrochloride, and dexamethasone during repeated courses of FOLFOX or FOLFIRI chemotherapy.
- Assess the effects of aprepitant on nausea, appetite, taste changes (via visual analogue scale), nutritional intake, and mucositis in these patients.
- Assess the safety of this regimen in these patients.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aprepitant and Palonosetron | Experimental | Drug: aprepitant, Drug: dexamethasone, Drug: fluorouracil, Drug: irinotecan hydrochloride, Drug: leucovorin calcium, Drug: oxaliplatin, Drug: palonosetron hydrochloride, Procedure: quality-of-life assessment |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| aprepitantAlso: Emend, MK-869, L-758,298, L-754,030Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle | Drug | Aprepitant and Palonosetron |
| dexamethasoneDexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4 | Drug | Aprepitant and Palonosetron |
| fluorouracilAlso: 5-FUas per institutional standard of care | Drug | Aprepitant and Palonosetron |
| irinotecan hydrochlorideAlso: Trade names: Camptosar®, Other names: Camptothecin-11, CPT-11as per institutional standard of care | Drug | Aprepitant and Palonosetron |
| leucovorin calciumAlso: Generic Name: Leucovorin, Other Names: Citrovorum Factor, Folinic Acidas per institutional standard of care | Drug | Aprepitant and Palonosetron |
| oxaliplatinAlso: Trade Name: Eloxatinas per institutional standard of care | Drug | Aprepitant and Palonosetron |
| palonosetron hydrochlorideAlso: AloxiPalonosetron 0.25 mg IV push on day 1 only. | Drug | Aprepitant and Palonosetron |
| quality-of-life assessmentbaseline | Procedure or surgery | Aprepitant and Palonosetron |
Primary outcome
Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.
Time frame: Up to 24 weeks
4 secondary outcomes
Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: within 5 days of chemotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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.
Joseph Bubalo, PharmD, BCPS, BCOP study chair
OHSU Knight Cancer Institute
6 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 aprepitant, dexamethasone and fluorouracil in people with Colorectal Cancer and Nausea and Vomiting, run by OHSU Knight Cancer Institute at 6 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: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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 10 Aug 2011). 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?
Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy. (time frame: Up to 24 weeks). 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 12 Jun 2017.