Ovarian CancerPhase 3NCT01704651
Accelerating Gastrointestinal Recovery
A Phase 3 study testing Alvimopan in people with Ovarian Cancer and Fallopian Tube Cancer, run by Jamie N. Bakkum-Gamez at 1 site in United States.
Trial summary
This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Alvimopan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Oct 2015
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females at least 18 years of age
- Have an American Society of Anesthesiologists (ASA) Score of I to III
- Are consented for primary, interval, or secondary cytoreduction for ovarian, tubal, or peritoneal cancer
- Are scheduled to have their nasogastric tube removed before the first postoperative dose of study medication
- Are able to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent
Who cannot join
- Females younger than 18 years of age
- Known non-gynecologic malignancy presenting with similar signs/symptoms as ovarian, tubal, or peritoneal cancer.
- Have taken more than 7 consecutive days of therapeutic doses of opioids immediately prior to surgery
- Use illicit drugs or abuse alcohol
- Have had a prior total colectomy, gastrectomy, gastric bypass, or have a functional colostomy or ileostomy
- Have an ongoing history of short bowel syndrome, chronic constipation (≤3 spontaneous bowel movements per week) or chronic diarrhea
Show all 14Show fewer
- Have received radiation therapy to the abdomen or pelvis within 3 months of scheduled surgery
- Have chemotherapy or radiation induced bowel dysfunction
- Are pregnant (identified by a positive urine or serum pregnancy test) or lactating, or are not postmenopausal (no menses for at least 1 year) and are of childbearing potential and not using an accepted method of birth control (ie, surgical sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam, or abstinence)
- Have participated in another investigational drug or medical device study within 30 days of surgery or will be enrolled in another investigational drug or medical device study or any study in which active patient participation is required outside normal hospital data collection during the course of this study
- Have clinically significant laboratory abnormalities at screening that would result in the cancellation of surgery
- Have a diagnosis of severe hepatic insufficiency or end stage renal disease.
- Have a history of previous surgeries, illness, or behavior that in the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures
- Are unable to understand the study procedures and are not able to voluntarily provided informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial
This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Being tested
- Alvimopan, Placebo
- Keywords
- Ovary, Ovarian, Fallopian, Peritoneal, Cancer, Gynecological, Female
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlvimopanDrug
Also called Entereg
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.
PlaceboDrug
Perioperative administration of placebo, at same dosing interval as study drug.
| Study group | Role | What they receive |
|---|---|---|
| Alvimopan | Experimental | Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. Receives: Drug: Alvimopan |
| Placebo | Placebo comparator | Perioperative administration of placebo, at same dosing interval as study drug. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Length of Hospital Stay
Length of stay = date/time of hospital dismissal - date/time of end of surgery
Measured: Patients will be followed for the duration of their hospital stay, an expected average of 5 days
Secondary outcomes (1)
Postoperative Ileus Incidence
Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.
Measured: Patients will be followed for 30 days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2015
- Study completionOct 2015
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 Ovarian CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jamie N. Bakkum-Gamez
- Sponsor type
- University, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Sponsor-investigator, Jamie N. Bakkum-Gamez, Mayo Clinic
- Investigators
- Jamie Bakkum-Gamez, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704651
- Sponsor's protocol ID
- 12-004082
- Status last verified
- Aug 2016
- First submitted
- 7 Oct 2012
- Last updated
- 24 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01704651
- Acronym / sponsor ID
- 12-004082
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Keywords
- Ovary, Ovarian, Fallopian, Peritoneal, Cancer, Gynecological, Female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Jamie N. Bakkum-GamezUniversity, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- Jan 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Posted 24 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alvimopan | Experimental | Drug: AlvimopanPerioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboPerioperative administration of placebo, at same dosing interval as study drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females at least 18 years of age
- Have an American Society of Anesthesiologists (ASA) Score of I to III
- Are consented for primary, interval, or secondary cytoreduction for ovarian, tubal, or peritoneal cancer
- Are scheduled to have their nasogastric tube removed before the first postoperative dose of study medication
- Are able to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent
Key exclusion criteria (14 listed)
- Females younger than 18 years of age
- Known non-gynecologic malignancy presenting with similar signs/symptoms as ovarian, tubal, or peritoneal cancer.
- Have taken more than 7 consecutive days of therapeutic doses of opioids immediately prior to surgery
- Use illicit drugs or abuse alcohol
- Have had a prior total colectomy, gastrectomy, gastric bypass, or have a functional colostomy or ileostomy
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 |
|---|---|---|
| AlvimopanAlso: EnteregPerioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. | Drug | Alvimopan |
| PlaceboPerioperative administration of placebo, at same dosing interval as study drug. | Drug | Placebo |
Primary outcome
Postoperative Length of Hospital Stay
Time frame: Patients will be followed for the duration of their hospital stay, an expected average of 5 days
Length of stay = date/time of hospital dismissal - date/time of end of surgery
1 secondary outcome
Postoperative Ileus Incidence
Time frame: Patients will be followed for 30 days postop
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Jamie Bakkum-Gamez, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alvimopan in people with Ovarian Cancer and Fallopian Tube Cancer, run by Jamie N. Bakkum-Gamez at 1 site 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?
The sponsor lists 5 inclusion and 14 exclusion criteria. 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 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 24 Oct 2016). 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?
Postoperative Length of Hospital Stay (time frame: Patients will be followed for the duration of their hospital stay, an expected average of 5 days). 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 Oct 2016.