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Phase III Double-Blind Trial Comparing Low-Molecular Weight Heparin (LMWH) Versus Placebo in Patients With Advanced Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer, Veno-occlusive Disease

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Trial Information

Phase III Double-Blind Trial Comparing Low-Molecular Weight Heparin (LMWH) Versus Placebo in Patients With Advanced Cancer


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. Patients receive dalteparin by subcutaneous injection
once daily plus standard therapy or standard therapy alone. Treatment continues for 1 year
in the absence of disease progression and unacceptable toxicity. Quality of life is assessed
before treatment, then every month for the first year, and then every 3 months for 2 years.
Patients are followed monthly for 1 year, then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 556 patients (278 per arm) will be accrued for this study
within 19 months.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Scott Okuno, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000066775

NCT ID:

NCT00003674

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Prostate Cancer
  • Veno-occlusive Disease
  • stage IV colon cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • recurrent non-small cell lung cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • stage IV non-small cell lung cancer
  • veno-occlusive disease
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Medcenter One Health SystemBismarck, North Dakota  58501