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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003674
Other study ID # NCCTG-979251
Secondary ID CDR0000066775NCI
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated July 12, 2016
Start date December 1998
Est. completion date April 2004

Study information

Verified date July 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 141
Est. completion date April 2004
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
dalteparin

standard therapy


Locations

Country Name City State
Canada Allan Blair Cancer Centre Regina Saskatchewan
United States CCOP - Ann Arbor Regional Ann Arbor Michigan
United States Medcenter One Health System Bismarck North Dakota
United States CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa
United States CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States CCOP - Duluth Duluth Minnesota
United States CCOP - Merit Care Hospital Fargo North Dakota
United States Altru Health Systems Grand Forks North Dakota
United States CCOP - Ochsner New Orleans Louisiana
United States CCOP - Missouri Valley Cancer Consortium Omaha Nebraska
United States Rapid City Regional Hospital Rapid City South Dakota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States CentraCare Clinic Saint Cloud Minnesota
United States CCOP - Scottsdale Oncology Program Scottsdale Arizona
United States Siouxland Hematology-Oncology Sioux City Iowa
United States CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota
United States CCOP - Toledo Community Hospital Oncology Program Toledo Ohio
United States CCOP - Carle Cancer Center Urbana Illinois
United States CCOP - Wichita Wichita Kansas

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival rate Up to 5 years No
Secondary Overall quality of life Up to 5 years No
Secondary Assess the incidence of symptomatic thrombotic events such as deep venous thrombosis (DVT), pulmonary embolus (PE), and clotted catheters Up to 5 years Yes
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