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.
* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
Given as a subcutaneous injection in the abdomen daily during chemotherapy treatment and then continuing daily for 1 year. Dose will vary.
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
North Shore Medical Center
Peabody, Massachusetts, United States
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.
Time frame: 2 years
To determine the effect of 2 different doses of enoxaparin sodium in combination with chemotherapy and chemotherapy alone on biomarkers of angiogenesis and to identify if these markers correlate with overall survival and progression free survival.
Time frame: 2 years
To evaluate toxicity and determine the rates of bleeding complications in this patient population.
Time frame: 2 years
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