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
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the prophylactic and treatment doses of Enoxaparin sodium given in combination with standard chemotherapy compared to standard chemotherapy alone with respect to time to tumor progression in this patient population.
Rachel Rosovsky, MD, MPH
Massachusetts General Hospital
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|North Shore Medical Center||Salem, Massachusetts 01970|