Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003674
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Brief Title:
Standard Therapy With or Without Dalteparin in Treating Patients With Advanced Breast Lung Colorectal or Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Double-Blind Trial Comparing Low-Molecular Weight Heparin LMWH Versus Placebo in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P98-0139 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066775 | REGISTRY | None | None |