Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-01-02 @ 3:53 PM
Study NCT ID:
NCT00916669
Status:
WITHDRAWN
Last Update Posted:
2013-05-08
First Post:
2009-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Study to Evaluate the Effect of Two Different Doses of Enoxaparin Sodium in Combination With Standard Chemotherapy in Patients With Stage Small Cell Lung Cancer (SCLC)
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Randomized Phase II Study to Evaluate the Effect of Two Different Doses of Enoxaparin Sodium in Combination With Standard Chemotherapy (Cisplatin Plus Etoposide) With Respect to Time to Tumor Progression (TTP) in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer (SCLC) Without Underlying Venous Thromboembolism
Status:
WITHDRAWN
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor withdrew funding prior to patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to see if adding enoxaparin sodium to standard treatment with the chemotherapy drugs cisplatin and etoposide will help treat extensive stage SCLC. Two different doses of enoxaparin sodium will be studied in order to determine if one dose is more effective than the other. Enoxaparin sodium (Lovenox) is a drug that is approved by the FDA to help treat or prevent blood clots. Results from previous research studies suggest that adding enoxaparin sodium to standard treatment improved the response to treatment for some study participants with various types of cancer.
Detailed Description:
* Since no one knows which of the study options are best, participants will be randomized into one of three study treatment groups. Group A will receive cisplatin and etoposide. Group B will receive cisplatin and etoposide plus low-dose enoxaparin sodium. Group C will receive cisplatin and etoposide plus high-dose enoxaparin sodium.
* Study treatment will be divided into chemotherapy and post-chemotherapy periods. All three groups (Group A, B and C) will receive six 3-week cycles of chemotherapy. Groups B and C will also receive daily enoxaparin sodium during the chemotherapy stage and daily enoxaparin sodium for 1 year after the chemotherapy.
* Cisplatin and etoposide are given as an infusion in 3-week cycles for up to six cycles. Enoxaparin sodium is given as an injection under the skin into the sides of the abdomen. Participants will be instructed in how to give themselves the injections.
* Study treatment will be divided into chemotherapy and post-chemotherapy periods. All three groups (Group A, B and C) will receive six 3-week cycles of chemotherapy. Groups B and C will also receive daily enoxaparin sodium during the chemotherapy stage and daily enoxaparin sodium for 1 year after the chemotherapy.
* Cisplatin and etoposide are given as an infusion in 3-week cycles for up to six cycles. Enoxaparin sodium is given as an injection under the skin into the sides of the abdomen. Participants will be instructed in how to give themselves the injections.
Study Oversight
Has Oversight DMC:
True
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?: