Know Cancer

forgot password

Multicenter, Randomized, Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Small Cell

Thank you

Trial Information

Multicenter, Randomized, Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer

There is clinical evidence indicative of the beneficial effects of heparin in the evolution
of patients with cancer. Apart from the studies that in an indirect way demonstrated an
increase in the survival of oncological patients who, because of presenting a venous
thromboembolism episode, were treated with low molecular weight heparin (LMWH) in comparison
with those treated with non-fractionated heparin; direct actions were also demonstrated from
the use of heparin in the survival and tumour progression. The administration of LMWH
together with Chemotherapy has been proved to increase the survival of patients diagnosed of
cancer of the pancreas in relation to those only treated with chemotherapy. An increase in
the global survival of advanced solid tumours, with no thromboembolic disease,has also been

All this suggests that an improvement in the survival of patients is observed when heparin
is added to the usual anti-tumour treatment, especially to those without spread disease, and
this effect seems to be independent of the protection against the thromboembolic

Inclusion Criteria:

1. Patients 18 years old or older, of either sex, with a diagnosis of limited small cell
lung cancer.

2. Patients with an ECOG functional state less than or equal to 2.

3. Informed consent to participate in the study.

4. Patients with a platelet count above 100,000/microlitre with no hemorrhagic

Exclusion Criteria:

1. Curative or palliative surgery as the initial treatment of their neoplastic

2. Patients with an active hemorrhage in the past two months, organic lesions
susceptible to bleeding (e.g. active peptic ulcer, hemorrhagic cerebrovascular
accident, aneurysms), history of clinically evident hemorrhagic episodes, major
surgery in the past month, outstanding clinically hemoptysis or an increased risk of
bleeding due to any homeostatic alteration that contraindicates anticoagulant

3. Known hypersensitivity to LMWH, heparin or substances of porcine origin.

4. Patients with hypersensitivity to the chemotherapeutic agents used in this protocol
that makes it impossible to use the antitumoral regime indicated in this protocol
(cisplatin or carboplatin and etoposide), i.e. hypersensitivity to cisplatin and
carboplatin or hypersensitivity to etoposide.

5. Patients with congenital or acquired bleeding diathesis.

6. Damage to/ or surgical interventions of the central nervous system, eyes and ears
within the past 6 months.

7. Acute bacterial endocarditis or slow endocarditis.

8. Patients with a history of heparin-associated thrombocytopenia or with a current
platelet count < 100,000/mm3

9. Patients with severe renal failure (serum creatinine over 2 mg/dl) or hepatic
insufficiency (with values of AST and/or ALT > 5 times the normal value established
in the reference range of the local hospital laboratory).

10. Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic
blood pressure above 120 mmHg).

11. Women who are pregnant or breast-feeding, or with the possibility of becoming
pregnant during the study.

12. Patients with suspected inability/or inability to comply with treatment and/or
complete the study.

13. Patients who are participating in another clinical trial or have done so in the past
30 days.

14. Patients with a life expectancy less than 3 months.

15. Patients on treatment with anticoagulants or who have been on treatment during three
months before the diagnosis of the tumor.

Type of Study:


Study Design:

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

Outcome Measure:

efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time)

Outcome Time Frame:


Safety Issue:


Principal Investigator

Alfonso Gúrpide, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clínica Universitaria de Navarra


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

June 2005

Completion Date:

September 2010

Related Keywords:

  • Carcinoma, Small Cell
  • Bemiparin
  • small cell lung carcinoma
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell