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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


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 life

Assess 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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