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| ID | Type | Description | Link |
|---|---|---|---|
| UMN-2006LS009 | Other Identifier | Clinical Trials Office, University of Minnesota | |
| UMN-0603M82707 | Other Identifier | IRB, University of Minnesota |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Treated with Fondaparinux | Experimental | Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fondaparinux sodium | Drug | Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 (Days 28-35) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
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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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Levi S. Downs, MD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Crozer-Chester Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Enrolled and Consented | This number includes all patients consented and enrolled in this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Upland |
| Pennsylvania |
| 19013 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 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. | The number includes those patients who completed the study and are evaluable for this outcome measure. | Posted | Number | Participants | Week 4 (Days 28-35) |
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| 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. | These patients completed the study and are considered evaluable for this outcome measure. | Posted | Number | Participants | Week 4 |
|
|
4 Weeks
33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
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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 | All Patients Who Received at Least One Dose of Fondaparinux | This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux. | 7 | 33 | 23 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Grade 5, death |
|
| Colitis (C. difficile) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Grade 3, severe |
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| Infection/Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Grade 5, death |
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| Partial small bowel obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 2, moderate |
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| Port-a-cath infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Grade 3, severe |
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| Pulmonary embolism, post-op | Vascular disorders | CTCAE (3.0) | Systematic Assessment | Grade 4, life-threatening |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 5, death |
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| Small bowel obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 4, life threatening |
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| Wound infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Grade 2, moderate |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety, increased | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Cold sensation, upper thighs & lower abdomen | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Decreased appetite (anorexia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dehyration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Emesis (vomiting) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Heartburn (dyspepsia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hematoma, retroperitoneal | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypoxia (oxygen desaturation) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Infection, wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Lung crackles | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Numbness (paresthesia), upper thighs, lower extremity, abdomen | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain, chest | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Sleep apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Sleeplessness | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Urine output, low | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
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| Vertigo | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Wound, draining | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Wound, open | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Levi S. Downs, Jr., M.D. | Masonic Cancer Center, University of Minnesota | 612-626-6628 | downs008@umn.edu |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D012509 | Sarcoma |
| D013923 | Thromboembolism |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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