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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00003674

Collaborator

National Cancer Institute (NCI) (NIH)

141

Enrollment

Locations

Arms

Duration (Months)

7.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Veno-occlusive Disease	Drug: dalteparin Drug: standard therapy	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

141 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 1998

Actual Primary Completion Date :

Apr 1, 2004

Actual Study Completion Date :

Apr 1, 2004

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall survival rate [Up to 5 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

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