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A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

Phase 3
18 Years
Open (Enrolling)
Small Cell Lung Cancer

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Trial Information

A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

Chemotherapy will be given in accordance with local or regional guidelines but shall include
a platinum drug + any topoisomerase inhibitor. Within these limits the study will accept
different local variants as long as each centre remains consistent to its declared standard
chemotherapy regimen. The recommended regimen is carboplatin or cisplatin plus etoposide q3
weeks for 4 cycles but up to 6 cycles is allowed. Local dosages and dose reduction schedules
will be used.

Inclusion Criteria:

1. Histologically or cytologically verified SCLC, all stages

2. WHO performance status 0, 1, 2 or 3

3. Age 18 years or older

4. Intention and feasibility to treat with chemotherapy consisting of platinum +
topoisomerase inhibitor.

5. Platelets >100 x109 /L

6. Signed informed consent

7. PK (prothrombin complex) INR and APTT within normal ranges.

Exclusion Criteria:

1. Prior systemic chemotherapy for lung cancer.

2. Concomitant anticoagulation treatment, except for ASA or clopidogrel

3. Active overt bleeding of clinical importance or at high risk (e.g. earlier observed
haemorrhage in a brain metastasis, severe coagulopathy as haemophilia, severe liver
dysfunction with impaired coagulation, acute peptic ulcer, and within the last 3
months suffered from intracranial haemorrhage, or surgery in the central nervous

4. Any other known contraindication for enoxaparine ( e.g. Hypersensitivity against
enoxaparine and its derivatives).

5. Pregnancy or breast-feeding

6. Fertile women not using effective contraceptives or men who do not agree to use
effective contraception during the treatment period.

7. Treatment with any other investigational agent, or participation in any other
clinical trial.

Type of Study:


Study Design:

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

Outcome Measure:

Significant increase of overall survival

Outcome Time Frame:

At follow up 1 year after treatment

Safety Issue:


Principal Investigator

Lars Ek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Lund


Sweden: Medical Products Agency

Study ID:

EudraCT number 2007-006033-14



Start Date:

June 2008

Completion Date:

December 2013

Related Keywords:

  • Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma