Cervical CancerPhase 2NCT00381888
Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer
A Phase 2 study testing fondaparinux sodium in people with Cervical Cancer and Endometrial Cancer, run by Masonic Cancer Center, University of Minnesota at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer
- What is being tested?
- fondaparinux sodium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to Jan 2009
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Crozer-Chester Medical Center
Upland, Pennsylvania, 19013
About this study
Official title: Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial
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.
Read the 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.
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Thromboembolism
- Being tested
- fondaparinux sodium
- 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
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Sarcoma, Thromboembolism, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fondaparinux sodiumDrug
Also called Artixtra(R)
Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Patients Treated with Fondaparinux | Experimental | Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth). Receives: Drug: fondaparinux sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4 (Days 28-35)
Secondary outcomes (1)
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.
Measured: Week 4
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 startJan 2007
- Primary completionJan 2009
- Study completionJan 2009
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 Cervical CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Levi S. Downs, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381888
- Sponsor's protocol ID
- CDR0000503985
- Other IDs
- UMN-2006LS009, UMN-0603M82707
- Status last verified
- Dec 2017
- First submitted
- 26 Sep 2006
- Last updated
- 28 Dec 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 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial
- ClinicalTrials.gov ID
- NCT00381888
- Acronym / sponsor ID
- CDR0000503985
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Thromboembolism
- Keywords
- thromboembolism, cervical cancer, endometrial cancer, ovarian epithelial cancer, ovarian germ cell tumor, borderline ovarian surface epithelial-stromal tumor, ovarian sarcoma, ovarian stromal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Posted 27 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Treated with Fondaparinux | Experimental | Drug: fondaparinux sodiumPatients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| fondaparinux sodiumAlso: Artixtra(R)Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth. | Drug | Patients Treated with Fondaparinux |
Primary outcome
Number of Patients With Venous Thromboembolism at Week 4
Time frame: 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.
1 secondary outcome
Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Levi S. Downs, MD principal investigator
Masonic Cancer Center, University of Minnesota
2 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 fondaparinux sodium in people with Cervical Cancer and Endometrial Cancer, run by Masonic Cancer Center, University of Minnesota at 2 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?
The sponsor lists 12 inclusion and 5 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 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 27 Jan 2010). 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 Patients With Venous Thromboembolism at Week 4 (time frame: Week 4 (Days 28-35)). 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 28 Dec 2017.