Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Conditions
Keywords
Ovary, Ovarian, Fallopian, Peritoneal, Cancer, Gynecological, Female
Brief 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.
Interventions
DRUGAlvimopan
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.
DRUGPlacebo
Perioperative administration of placebo, at same dosing interval as study drug.
Sponsors
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Jamie N. Bakkum-Gamez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Length of Hospital Stay | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Ileus Incidence | Patients will be followed for 30 days postop | Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus. |
Countries
United States
Participant flow
Recruitment details
The study took place at Mayo Clinic in Rochester, Minnesota from January 2013 to June 2015.
Participants by arm
| Arm | Count |
|---|---|
| Alvimopan 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. | 66 |
| Placebo Perioperative administration of placebo, at same dosing interval as study drug. | 68 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Nasogastric tube placement in surgery | 1 | 1 |
| Overall Study | Post-op did not have laparotomy | 2 | 1 |
| Overall Study | Pre-op change in treatment plan | 1 | 4 |
| Overall Study | Pre-op withdrawal by subject | 1 | 1 |
Baseline characteristics
| Characteristic | Alvimopan | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 10.2 | 63.7 years STANDARD_DEVIATION 11.2 | 62.1 years STANDARD_DEVIATION 10.8 |
| Cancer Stage Benign pelvic masses | 2 participants | 6 participants | 8 participants |
| Cancer Stage I/II | 17 participants | 8 participants | 25 participants |
| Cancer Stage III/IV | 33 participants | 40 participants | 73 participants |
| Cancer Stage Other non-ovarian primary cancers | 2 participants | 3 participants | 5 participants |
| Cancer Stage Recurrent disease | 12 participants | 11 participants | 23 participants |
| Region of Enrollment United States | 66 participants | 68 participants | 134 participants |
| Residual Disease No | 48 participants | 50 participants | 98 participants |
| Residual Disease Yes, extensive (multiple sites/organs) | 6 participants | 5 participants | 11 participants |
| Residual Disease Yes, measurable (</= 1 cm) | 12 participants | 11 participants | 23 participants |
| Residual Disease Yes, suboptimal (>1 cm, limited sites) | 0 participants | 2 participants | 2 participants |
| Sex: Female, Male Female | 66 Participants | 68 Participants | 134 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgery Type Interval debulking | 9 participants | 11 participants | 20 participants |
| Surgery Type Primary surgery | 45 participants | 46 participants | 91 participants |
| Surgery Type Secondary debulking | 12 participants | 11 participants | 23 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 52 / 66 | 57 / 68 |
| serious Total, serious adverse events | 9 / 66 | 10 / 68 |
Outcome results
Primary
Postoperative Length of Hospital Stay
Length of stay = date/time of hospital dismissal - date/time of end of surgery
Time frame: Patients will be followed for the duration of their hospital stay, an expected average of 5 days
Population: Intent to Treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alvimopan | Postoperative Length of Hospital Stay | 4.4 days | Standard Deviation 2.7 |
| Placebo | Postoperative Length of Hospital Stay | 4.3 days | Standard Deviation 2.9 |
p-value: 0.34t-test, 2 sided
Secondary
Postoperative Ileus Incidence
Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.
Time frame: Patients will be followed for 30 days postop
Population: Intent to treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan | Postoperative Ileus Incidence | 7 participants |
| Placebo | Postoperative Ileus Incidence | 13 participants |
p-value: 0.17t-test, 2 sided