Standard Therapy With or Without Dalteparin in Treating Patients With Advanced Breast, Lung, Colorectal, or Prostate Cancer

July 12, 2016 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5404
        • CCOP - Scottsdale Oncology Program
    • Illinois
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, United States, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Sioux City, Iowa, United States, 51101-1733
        • Siouxland Hematology-Oncology
    • Kansas
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • CCOP - Ochsner
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Ann Arbor Regional
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • CCOP - Missouri Valley Cancer Consortium
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Health System
      • Fargo, North Dakota, United States, 58122
        • CCOP - Merit Care Hospital
      • Grand Forks, North Dakota, United States, 58201
        • Altru Health Systems
    • Ohio
      • Toledo, Ohio, United States, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57709
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57105-1080
        • CCOP - Sioux Community Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dalteparin + standard therapy
Patients receive dalteparin by subcutaneous injection once daily plus standard therapy. 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.
Drug: dalteparin
Drug: standard therapy
Active Comparator: standard therapy
Patients receive 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.
Drug: standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival rate
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall quality of life
Time Frame: Up to 5 years
Up to 5 years
Assess the incidence of symptomatic thrombotic events such as deep venous thrombosis (DVT), pulmonary embolus (PE), and clotted catheters
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 13, 2004

First Posted (Estimate)

April 14, 2004

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-979251
  • CDR0000066775 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-P98-0139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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