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)
NCT ID: NCT00916669
Last Updated: 2013-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2008-07-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Cisplatin and Etoposide
Etoposide
Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
Cisplatin
Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
Group B
Cisplatin and etoposide, plus low-dose enoxaparin sodium
Etoposide
Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
Cisplatin
Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
enoxaparin sodium
Given as a subcutaneous injection in the abdomen daily during chemotherapy treatment and then continuing daily for 1 year. Dose will vary.
Group C
Cisplatin and etoposide, plus high-dose enoxaparin sodium
Etoposide
Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
Cisplatin
Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
enoxaparin sodium
Given as a subcutaneous injection in the abdomen daily during chemotherapy treatment and then continuing daily for 1 year. Dose will vary.
Interventions
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Etoposide
Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
Cisplatin
Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
enoxaparin sodium
Given as a subcutaneous injection in the abdomen daily during chemotherapy treatment and then continuing daily for 1 year. Dose will vary.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented extensive disease small cell lung cancer. Only small cell histology is eligible. Mixed histology is not eligible. Patients who are considered to have operable disease are not eligible
* Radiographic measurable disease by RECIST criteria
* Life expectancy of greater than 4 months and ECOG Performance Status of less than or equal to 2
* Patients must be an appropriate candidate for the standard combination of cisplatin and etoposide for SCLC. There are no restrictions on radiotherapy
* No prior chemotherapy for SCLC cancer
* Participants must meet the hematological, renal and hepatic function requirements outlined in the protocol
* If brain or bone metastases are present at the time of initial diagnosis, patients must have completed radiation treatment at least 2 weeks before starting the study
* No active uncontrolled infection
* No other serious illness or medical condition that in the opinion of the investigator would be expected to interfere with the subject's ability to receive study treatment or comply with study procedures
Exclusion Criteria
* Indication for anticoagulant treatment such as mechanical heart valves, atrial fibrillation, or previous VTE
* Contraindication or known hypersensitivity to LMWH or unfractionated heparin (UFH)
* Active bleeding disorder
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or breast feeding women
* Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers will are eligible if diagnosed and treated within the past 5 years; cervical in situ, and basal cell or squamous cell carcinoma of the skin
* HIV-positive individuals on combination antiretroviral therapy are ineligible
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Beth Israel Deaconess Medical Center
OTHER
North Shore Medical Center
OTHER
Sanofi
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Rachel P. Rosovsky, MD
Physician
Principal Investigators
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Rachel Rosovsky, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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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
Countries
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Other Identifiers
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08-097
Identifier Type: -
Identifier Source: org_study_id
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