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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- 18 years of age or older

- 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:

- New (defined as 6 months or less) or symptomatic thrombosis at the time of enrollment

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Rachel Rosovsky, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

08-097

NCT ID:

NCT00916669

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Small Cell Lung Cancer
  • SCLC
  • enoxaparin sodium
  • cisplatin
  • etoposide
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Venous Thromboembolism

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
North Shore Medical CenterSalem, Massachusetts  01970