Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Bemiparin

About this trial

This is an interventional treatment trial for Carcinoma, Small Cell focused on measuring Bemiparin, small cell lung carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients 18 years old or older, of either sex, with a diagnosis of limited small cell lung cancer. Patients with an ECOG functional state less than or equal to 2. Informed consent to participate in the study. Patients with a platelet count above 100,000/microlitre with no hemorrhagic symptomatology. Exclusion Criteria: Curative or palliative surgery as the initial treatment of their neoplastic condition. 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 therapy. Known hypersensitivity to LMWH, heparin or substances of porcine origin. 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. Patients with congenital or acquired bleeding diathesis. Damage to/ or surgical interventions of the central nervous system, eyes and ears within the past 6 months. Acute bacterial endocarditis or slow endocarditis. Patients with a history of heparin-associated thrombocytopenia or with a current platelet count < 100,000/mm3 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). Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure above 120 mmHg). Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study. Patients with suspected inability/or inability to comply with treatment and/or complete the study. Patients who are participating in another clinical trial or have done so in the past 30 days. Patients with a life expectancy less than 3 months. Patients on treatment with anticoagulants or who have been on treatment during three months before the diagnosis of the tumor.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

Control

Arm Description

Bemiparin 3,500 IU

Outcomes

Primary Outcome Measures

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)

safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings.

Secondary Outcome Measures

Full Information

NCT ID

NCT00324558

First Posted

May 9, 2006

Last Updated

June 7, 2012

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

1. Study Identification

Unique Protocol Identification Number

NCT00324558

Brief Title

Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Terminated

Why Stopped

Sponsor stopped due to difficulties to recruit 130 patients required by protocol

Study Start Date

June 2005 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

Main objective: To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases progression-free survival. Secondary objectives: To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting with the onset of chemotherapy, increases global survival, improving the response rates to treatment with CT + RT (radiotherapy) and reduces the incidence of venous thromboembolism (VTE).

Detailed Description

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 showed. 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 complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Small Cell

Keywords

Bemiparin, small cell lung carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

Bemiparin 3,500 IU

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Bemiparin

Intervention Description

subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT)

Primary Outcome Measure Information:

Title

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)

Time Frame

efficacy

Title

safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings.

Time Frame

safety

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients 18 years old or older, of either sex, with a diagnosis of limited small cell lung cancer. Patients with an ECOG functional state less than or equal to 2. Informed consent to participate in the study. Patients with a platelet count above 100,000/microlitre with no hemorrhagic symptomatology. Exclusion Criteria: Curative or palliative surgery as the initial treatment of their neoplastic condition. 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 therapy. Known hypersensitivity to LMWH, heparin or substances of porcine origin. 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. Patients with congenital or acquired bleeding diathesis. Damage to/ or surgical interventions of the central nervous system, eyes and ears within the past 6 months. Acute bacterial endocarditis or slow endocarditis. Patients with a history of heparin-associated thrombocytopenia or with a current platelet count < 100,000/mm3 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). Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure above 120 mmHg). Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study. Patients with suspected inability/or inability to comply with treatment and/or complete the study. Patients who are participating in another clinical trial or have done so in the past 30 days. Patients with a life expectancy less than 3 months. Patients on treatment with anticoagulants or who have been on treatment during three months before the diagnosis of the tumor.

Overall Study Officials: