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

Primary Purpose

Breast Cancer, Colorectal Cancer, Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dalteparin
standard therapy
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • Siouxland Hematology-Oncology
  • CCOP - Wichita
  • CCOP - Ochsner
  • CCOP - Ann Arbor Regional
  • CCOP - Duluth
  • Mayo Clinic Cancer Center
  • CentraCare Clinic
  • CCOP - Missouri Valley Cancer Consortium
  • Medcenter One Health System
  • CCOP - Merit Care Hospital
  • Altru Health Systems
  • CCOP - Toledo Community Hospital Oncology Program
  • CCOP - Geisinger Clinic and Medical Center
  • Rapid City Regional Hospital
  • CCOP - Sioux Community Cancer Consortium
  • Allan Blair Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dalteparin + standard therapy

standard therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall survival rate

Secondary Outcome Measures

Overall quality of life
Assess the incidence of symptomatic thrombotic events such as deep venous thrombosis (DVT), pulmonary embolus (PE), and clotted catheters

Full Information

First Posted
November 1, 1999
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003674
Brief Title
Standard Therapy With or Without Dalteparin in Treating Patients With Advanced Breast, Lung, Colorectal, or Prostate Cancer
Official Title
Phase III Double-Blind Trial Comparing Low-Molecular Weight Heparin (LMWH) Versus Placebo in Patients With Advanced Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer, Veno-occlusive Disease
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dalteparin + standard therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
standard therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
dalteparin
Intervention Type
Drug
Intervention Name(s)
standard therapy
Primary Outcome Measure Information:
Title
Overall survival rate
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Overall quality of life
Time Frame
Up to 5 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Okuno, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
Siouxland Hematology-Oncology
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CentraCare Clinic
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Medcenter One Health System
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Altru Health Systems
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57709
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105-1080
Country
United States
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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