Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Rare Diseases

Obesity

Body Weight

Thromboembolism

Venous Thromboembolism

Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Acute Graft Versus Host Disease

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Heparin

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Participants will receive a daily subcutaneous injection of weight-adjusted dalteparin (See Table below) at a dose of approx. 200 IU/kg beginning on the day of enrolment and for a one month.

91 to 95 kg: 18,000 IU daily ( or 1 prefilled syringe of 18,000 IU) 96 to 105 kg: 20,000 IU daily ( or 2 prefilled syringes of 10,000 IU) 106 to 120 kg: 22,500 IU daily ( or 2 pre-filled syringes (10,000 and 12,500 IU)) 121 to 130 kg: 25,000 IU daily ( or 2 prefilled syringes of 12,500 IU) 131 to 145 kg: 27,500 IU daily ( or 2 pre-filled syringes (12,500 and 15,000 IU)) 146 to 150 kg: 30,000 IU daily ( or 2 prefilled syringes of 15,000 IU)

≥ 151 kg: 33,000 IU daily ( or 2 prefilled syringes (15,000 and 18,000 IU))

daily subcutaneous injection of weight-adjusted dalteparin

Marc Carrier, MD

Cancer patients that develop blood clots are treated with low molecular weight heparin injections (LMWH). One kind of these LMWHs, dalteparin, has its dose determined based on a patient's weight using a formula of 200 international units (IU) per kilogram (kg). The current dosing of dalteparin approved by Health Canada has a maximum daily dose of 18 000 IU/day which is weight-adjusted for patients up to 90 kg. Any patient weighing more than 90 kg would take the same dosage regardless of their weight. The aim of this study is to assess the safety of using weight-adjusted dalteparin in cancer-associated venous thromboembolism patients that weigh more than 90 kg.

The study is designed as a multicentre prospective cohort study with multiple Canadian sites. It will be initiated at The Ottawa Hospital prior to being offered externally. After obtaining informed consent, and confirming eligibility, participants weighing more than 90 kg with acute cancer-associated thrombosis will be treated with therapeutic weight-adjusted dalteparin (subcutaneous once daily injection, or twice daily, if the conditions of the participant do not allow once daily injection as per clinical judgement) beginning at enrolment (within 12 hours) and continuing until Day 30 visit. Subjects will receive therapeutic doses of dalteparin at a dose of approximately 200 IU/kg SC daily (up to 33,000 IU) for one month. Following this study period of 30 days (± 4 days), patients will be followed for 5 months. During the follow-up period, each patient will pursue his/her treatment as per usual standard treatment protocols provided at each institution. Treatment used and clinical outcomes will be collected at the end of the follow-up period.

The majority of Canadian Thrombosis specialists use weight adjusted dosing of dalteparin in patients weighing more than 90 kg with cancer-associated VTE. No expert recommends capping the dose of dalteparin to 18,000 IU in patients weighing over 90 kg as suggested by the product monograph. However, the risk of major bleeding episodes in patients over 90 kg receiving weight-adjusted LMWH remains unclear. The estimated rate of major bleeding episodes of patients with cancer associated VTE (Mean weight 79.1 kg) managed with therapeutic dose of dalteparin is 3.6% (95% CI: 1.9 to 6.2). We hypothesize that the rate of major bleeding events will be similar in patients (\> 90 kg) with cancer-associated VTE treated with dalteparin 200 IU/kg daily (up to 33,000 IU). We plan to recruit 150 patients in this cohort study. We expect 6 major bleeding events. This would provide us with an overall bleeding event of 4% with an upper bound of the confidence interval of 8.5%). An informal survey of Canadian thrombosis expert has demonstrated that clinicians would feel reassured and continue to use weight-adjusted dalteparin in cancer patients weighing more than 90kg if the upper bound of the 95% confidence interval is less than 9% (i.e. \< 3% possible absolute rate difference).

WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism

A Multicentre Prospective Cohort Study Assessing the Use of Weight-Adjusted Low-Molecular-Weight-Heparin in Patients Over 90 kg With Acute Cancer-Associated Venous Thromboembolism

1. Fatal bleeding, and/or,
2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or,
3. Bleeding causing a fall in hemoglobin level of ≥20 g/L, or leading to transfusion of ≥2 units of whole blood or red cells.

As overt bleeding episodes not meeting the inclusion for major bleeding but associated with one of the following:

1. Medical intervention,
2. An unscheduled contact with a physician,
3. Temporary cessation of anticoagulant treatment.

Overt bleeding not meeting the major bleeding or clinically-relevant non-major bleeding definitions

1. Recurrent deep vein thrombosis
2. Recurrent Pulmonary embolism

Trough anti-Xa levels measured at Day 7 and Day 30 follow-up visits will be generated for the once and twice-daily dosing regimen

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

Ottawa Hospital Research Institute

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Venous Thrombosis

Pancreatic Neoplasms

Pulmonary Embolism

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.

5000 units subcutaneous, by injection under the skin, daily for 16 weeks

Saroj Vadhan-Raj, MD

The goal of this clinical research study is to learn if dalteparin can lower the risk of VTE occurring in the legs and lungs. This will be tested in patients with pancreatic cancer who are going to receive chemotherapy. Some patients will receive dalteparin and some will receive no study drug.

The safety of dalteparin will also be studied.

Study Drug:

Dalteparin is designed to thin the blood and block blood from clotting. This may lower the risk of VTE.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) into 1 of 2 groups. There is an equal chance of being assigned to either group.

Group 1 will receive dalteparin.

Group 2 will not receive a study drug.

During this study, all study participants will be routinely checked for VTE by ultrasounds and CT scans.

You may also receive standard therapies for preventing VTE. This may include blood-thinning drugs while you are in the hospital, getting up and moving around at least 5 times per day, and/or wearing special stockings or boot-like devices designed to put pressure on the feet.

Genetic Research Testing:

Before starting your therapy (at baseline), blood (about 1 teaspoon) will be drawn and stored for genetic testing. Researchers want to use DNA (the genetic material in cells) to look for markers that may be related to having a high risk for developing blood clots. The samples will be processed and stored at MD Anderson. Once this study ends, the DNA will be tested further in Dr. Futreal's laboratory and/or may be shipped outside to Illumina Sequencing Services (San Diego, CA) for genetic research. The samples will be deidentified before shipping.

Before your samples are sent to the outside laboratory for banking, your name and any personal identifying information will be coded to protect your privacy. The outside researchers will not have access to the codes that link the samples to your identity.

Study Drug Administration:

If you are in Group 1, you will receive dalteparin by injection under your skin, once a day for 16 weeks. You and/or your caregiver will be taught how to perform injections.

Study Visits:

At every study visit, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature and breathing rate).
* Your medical history will be recorded.

About every 2 weeks after chemotherapy starts until Week 16, blood (about 2 teaspoons) will be drawn for routine tests. This test may be repeated more often if the doctor decides it is needed.

Before each new cycle of chemotherapy during Weeks 1-16, blood (about 2 teaspoons) will be drawn for routine tests to check the function of your liver and kidneys.

At Weeks 8 and 16 (+/- 7 days), the following procedures will be performed:

* You will have an ultrasound of your legs to check for blood clots.
* If the doctor decides it is needed, you will have CT scans to check the status of the cancer. Researchers will also check your chest CT scans to look for blood clots in the lungs.

Length of Study Participation:

You may remain on study for up to 16 weeks. You will be taken off study early if blood clots occur or you experience intolerable side effects.

Follow-Up Phone Calls:

This study has a 3-year follow-up period. In Year 1, you will receive a follow-up phone call from the study staff in the first month and then at Months 3, 6, 9, and 12. In Years 2 and 3, you will be called every 6 months.

The study staff will ask about your overall health. In the first phone call, you will also be asked about any side effects that may have occurred.

This is an investigational study. Dalteparin is commercially available and FDA approved for use in preventing VTE that may occur for other reasons. Those reasons include abdominal surgery; surgery for a hip fracture, hip replacement, or knee replacement; and illnesses causing patients to be unable to move around.

Dalteparin is also commercially available and FDA approved to treat VTE in cancer patients. However, it is investigational to use dalteparin to prevent VTE in cancer patients receiving chemotherapy.

Up to 87 patients will take part in this study. All will be enrolled at MD Anderson.

Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients

Randomized Clinical Trial of Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients Undergoing Chemotherapy Treatment.

Venous thromboembolism (VTE) defined by both symptomatic and asymptomatic VTE which includes deep venous thrombosis (DVT) and pulmonary embolism (PE) through clinical assessments and radiologic studies. All patients undergo bilateral lower extremity ultrasound every 2 months while on study (total of 3 exams including pre-randomization). VTE requires imaging documentation to evaluate use of prophylactic anticoagulation in reducing the occurrence of VTE in a patient population with a known high risk of VTE.

Eisai Inc.

M.D. Anderson Cancer Center

Group 1: Dalteparin

Group 2: Control

Total

Age, Continuous

>=60

Age, Customized

Sex: Female, Male

Black or African American

Causacian

Hispanic

Other

Unknown or Unreported

Race/Ethnicity, Customized

United States

Region of Enrollment

Saroj Vadhan-Raj, MD/Professor, Sarcoma Medical Oncology

Number of Participants With Venous Thromboembolic Events (VTE)

No Dalteparin study drug (primary prophylaxis).

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy

dalteparin

Laurie Elit, MD

Agnes Lee, MD

Mark Levine, MD

Jim Julian, MMath

Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term survival is poor for the majority of women with EOC because many present with advanced disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in survival and is associated with unacceptable toxicity. This phase II, dose-finding, open label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3 doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based chemotherapy. The primary outcome is disease response, measured according to Gynaecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin associated with the best response will be tested further in a phase III randomized clinical trial in the same patient population.

Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

Pfizer

Ontario Clinical Oncology Group (OCOG)

Dr. Mark Levine

Nervous System Diseases

Glioma

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

James Perry, MD

William Geerts, MD

In patients with malignant glioma, to determine the efficacy of prophylaxis with LMWH (dalteparin) compared to placebo, both commenced beyond the immediate postoperative period, for the prevention of VTE.

Patients are randomized 1:1 to receive dalteparin 5,000 anti-Xa units s.c. daily versus placebo s.c. daily. The primary outcome is VTE-free survival at 6 months. Progression free survival; overall survival, toxicity, and neurocognitive performance are secondary outcome measures.

Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients

A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism	NCT03297359	Cancer Venous Thromboe... Obesity	Dalteparin	18 Years -	Ottawa Hospital Research Institute
Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients	NCT00966277	Pancreatic Canc... Venous Thromboe...	Dalteparin	18 Years -	M.D. Anderson Cancer Center
Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)	NCT00239980	Ovarian Cancer	dalteparin	18 Years - 75 Years	Ontario Clinical Oncology Group (OCOG)
Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients	NCT00135876	Venous Thromboe... Brain Tumors	dalteparin	18 Years -	Ontario Clinical Oncology Group (OCOG)
Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)	NCT00239980	Ovarian Cancer	dalteparin	18 Years - 75 Years	Ontario Clinical Oncology Group (OCOG)
WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism	NCT03297359	Cancer Venous Thromboe... Obesity	Dalteparin	18 Years -	Ottawa Hospital Research Institute

Spots Global Cancer Trial Database for fragmin

Every month we try and update this database with for fragmin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fragmin

Every month we try and update this database with for fragmin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fragmin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.