Standard Therapy With or Without Dalteparin in Treating Patients With Advanced Breast, Lung, Colorectal, or Prostate Cancer
Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer; Veno-occlusive Disease
Intervention: dalteparin (Drug); standard therapy (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alliance for Clinical Trials in Oncology Official(s) and/or principal investigator(s): Scott Okuno, MD, Study Chair, Affiliation: Mayo Clinic
Summary
RATIONALE: Dalteparin may be effective in inhibiting the growth of blood vessels in tumors,
decreasing the risk of metastatic cancer, preventing the formation of blood clots, and
improving quality of life in treating patients with advanced cancer that has not responded
to previous treatment. It is not yet known if standard therapy is more effective with or
without dalteparin in treating advanced breast, lung, colorectal, and prostate cancer.
PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of standard
therapy with or without dalteparin in treating patients who have advanced breast, lung,
colorectal, or prostate cancer that has not responded to previous chemotherapy or hormone
therapy.
Clinical Details
Official title: Phase III Double-Blind Trial Comparing Low-Molecular Weight Heparin (LMWH) Versus Placebo in Patients With Advanced Cancer
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Overall survival rate
Secondary outcome: Overall quality of lifeAssess the incidence of symptomatic thrombotic events such as deep venous thrombosis (DVT), pulmonary embolus (PE), and clotted catheters
Detailed description:
OBJECTIVES: I. Compare the effect of low molecular weight heparin (dalteparin) plus standard
therapy versus standard therapy alone on the overall survival rate of patients with advanced
cancers. II. Compare the toxic effects of these regimens and the effect on the quality of
life of these patients. III. Assess the incidence of symptomatic thrombotic events such as
deep venous thrombosis (DVT), pulmonary embolus (PE), and clotted catheters in these
patients.
OUTLINE: This is a randomized study. Patients are stratified according to prognostic index
(good vs bad vs unsure), current therapy (systemic vs radiation vs both vs none), age (50 or
under vs over 50), disease site (breast vs colon vs small cell lung vs nonsmall cell lung vs
prostate), history of prior thrombotic event over 1 year ago (yes vs no), and gender.
Patients are randomized to receive low molecular weight heparin (dalteparin) plus standard
therapy or standard therapy alone.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically proven breast, lung, colorectal,
or prostate cancer that has failed prior chemotherapy or hormone therapy No active CNS
metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance
status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3500/mm3
Platelet count at least 150,000/mm3 Fibrinogen above lower limits of normal Hepatic:
Bilirubin no greater than 1. 5 times upper limit of normal (ULN) SGOT no greater than 3
times ULN Prothrombin time no greater than 1. 5 times ULN Active partial thromboplastin
time no greater than 1. 5 times ULN Renal: Creatinine no greater than 1. 5 times ULN Other:
No history of heparin associated thrombocytopenia At least 1 year since prior
thromboembolic phenomenon such as deep venous thrombosis, pulmonary embolus, or clotted
catheter No prior intolerance of unfractionated or low molecular weight heparin
PRIOR CONCURRENT THERAPY: No concurrent anticoagulation therapy No concurrent enrollment
on systemic or radiation therapy study (therapy off study allowed)
Locations and Contacts
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States
Siouxland Hematology-Oncology, Sioux City, Iowa 51101-1733, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Ochsner, New Orleans, Louisiana 70121, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States
CCOP - Duluth, Duluth, Minnesota 55805, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CentraCare Clinic, Saint Cloud, Minnesota 56303, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States
Medcenter One Health System, Bismarck, North Dakota 58501, United States
CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States
Altru Health Systems, Grand Forks, North Dakota 58201, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio 43623-3456, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania 17822-2001, United States
Allan Blair Cancer Centre, Regina, Saskatchewan S4T 7T1, Canada
Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57105-1080, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 1998
Last updated: July 7, 2015
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