Trial | NCT01374373  Report issue

Title

Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia
A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    epoetin ...

  • Study Participants

    30
The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy.
Patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy will enter this 12 week single arm open label study. Epoetin alfa 40.000-60.000 IU/week will be administered subcutaneously and controlled every 2 weeks. Up or down titration will be performed according to the currently approved prescription guidance for a total of 12 weeks of treatment. Study end points will be assessed every 4 weeks until final 12 week visit.
Study Started
Jun 30
2011
Primary Completion
Nov 30
2014
Study Completion
Nov 30
2014
Last Update
Apr 07
2016
Estimate

Biological Epoetin alfa

Epoetin alfa 40.000-60.000 IU/week subcutaneously that will be controlled and up or down titrated every 2 weeks according to the currently approved prescription guidance for a total of 12 weeks of treatment with Co administration of oral ferrous sulfate 200mg BID and oral folic acid 5mg QD

Open Label Other

One arm open label

Criteria 

Inclusion Criteria:

Confirmed diagnosis of non curable cancer or lymphoma
Receiving a palliative chemotherapy regimen
Hemoglobin < 10.0 g/dL
Performance ≤ 3 of Eastern Cooperative Oncology Group (ECOG) performance status
Life expectancy of ≥ 3 months
Postmenopausal o premenopausal women receiving effective contraceptive method

Exclusion Criteria:

Active bleeding that may have caused anemia in the prior 30 days.
Uncontrolled hypertension
Anemia for another cause other than cancer or chemotherapy
Untreated iron or folic acid deficiency
Transfusion in the last 30 days prior to baseline visit
Treatment with an erythropoiesis stimulating agent 3 months prior to the baseline visit
Increased risk of thromboembolic disease
Radiotherapy in pelvis or spine in the last 60 days
Myelodysplasic syndrome
History of congestive heart failure
Pregnant or lactating
Patient with known allergy to human albumin or related products
No Results Posted