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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003674 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer Cancer-Related Problem/Condition Colorectal Cancer Lung Cancer Prostate Cancer |
Drug: dalteparin Procedure: quality-of-life assessment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Phase III Double-Blind Trial Comparing Low-Molecular Weight Heparin (LMWH) Versus Placebo in Patients With Advanced Cancer |
| Estimated Enrollment: | 556 |
| Study Start Date: | December 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CentraCare Clinic | |
| Saint Cloud, Minnesota, United States, 56303 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68131 | |
| United States, North Dakota | |
| Altru Health Systems | |
| Grand Forks, North Dakota, United States, 58201 | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Medcenter One Health System | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| United States, Pennsylvania | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57105-1080 | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Study Chair: | Scott Okuno, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000066775, NCCTG-979251, NCI-P98-0139 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003674 |
| Health Authority: | United States: Federal Government |
|
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 quality of life |
|
Thoracic Neoplasms Prostatic Diseases Genital Neoplasms, Male Rectal Neoplasms Gastrointestinal Diseases Heparin, Low-Molecular-Weight Colonic Diseases Quality of Life Urogenital Neoplasms Rectal Diseases Calcium heparin Body Weight Respiratory Tract Diseases Lung Neoplasms Heparin |
Rectal cancer Breast Diseases Non-small cell lung cancer Digestive System Neoplasms Skin Diseases Breast Neoplasms Intestinal Diseases Genital Diseases, Male Intestinal Neoplasms Recurrence Rectal neoplasm Carcinoma, Small Cell Digestive System Diseases Dalteparin Lung Diseases |
|
Respiratory Tract Neoplasms Fibrin Modulating Agents Neoplasms Anticoagulants Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |
