Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Thromboembolism, Vaginal Cancer, Vulvar Cancer
Conditions
Keywords
thromboembolism, cervical cancer, endometrial cancer, ovarian epithelial cancer, ovarian germ cell tumor, borderline ovarian surface epithelial-stromal tumor, ovarian sarcoma, ovarian stromal cancer, uterine sarcoma, vaginal cancer, vulvar cancer, fallopian tube cancer
Brief summary
RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are undergoing surgery for gynecologic cancer. PURPOSE: This phase II trial is studying how well fondaparinux works in preventing blood clots in patients undergoing surgery for gynecologic cancer.
Detailed description
OBJECTIVES: Primary * Evaluate the efficacy of prolonged (4 weeks) fondaparinux sodium administration in venous thromboembolism prophylaxis in patients undergoing gynecologic oncology surgery. Secondary * Evaluate the safety of this regimen in these patients (4 weeks). * Determine the feasibility of this regimen in these patients (4 weeks). OUTLINE: This is an open-label study. Beginning after surgery, patients receive fondaparinux sodium subcutaneously once daily on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients undergo duplex ultrasonography of the lower extremities between day 28-35.
Interventions
Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo major, open abdominal-pelvic surgery for known or presumed gynecologic malignancy * Age 18 years or older at the time of signing the consent * Gynecologic Oncology Group (GOG) performance status of ≤ 2 * Life expectancy of \> 3 months * Patient's weight must be ≥ 50 kg * Adequate organ function within 28 days of study entry defined as: * Hemoglobin ≥ 9.0 g/dL * Platelet ≥ 100,000 x 109/L * Blood urea nitrogen (BUN) ≤ 30 mg/dL * Serum creatinine ≤ 1.5 mg/dL * Not pregnant as determined by a negative urine or serum pregnancy test within 14 days of study enrollment * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Exclusion criteria
* Current treatment with anticoagulants * Thromboembolism within the previous 6 months * Bleeding/blood disorders (e.g., thrombocytopenia), gastrointestinal bleeding (e.g., active ulcers), history of stroke within past 3 years, or severe and currently uncontrolled high blood pressure * Bacterial endocarditis * Known hypersensitivity to fondaparinux sodium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Venous Thromboembolism at Week 4 | Week 4 (Days 28-35) | Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4. | Week 4 | This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Enrolled and Consented This number includes all patients that were consented and enrolled in the study and received at least one dose of study drug. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Had laparoscopic surgery | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 9 |
| Overall Study | Surgery was cancelled | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Patients Enrolled and Consented |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 55.7 Years |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 33 |
| serious Total, serious adverse events | 7 / 33 |
Outcome results
Primary
Number of Patients With Venous Thromboembolism at Week 4
Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.
Time frame: Week 4 (Days 28-35)
Population: The number includes those patients who completed the study and are evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fondaparinux Patients Who Completed Study | Number of Patients With Venous Thromboembolism at Week 4 | 0 Participants |
Secondary
Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.
This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition.
Time frame: Week 4
Population: These patients completed the study and are considered evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fondaparinux Patients Who Completed Study | Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4. | 27 Participants |