NCT01374373

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

3.4 years

First QC Date

June 13, 2011

Last Update Submit

April 6, 2016

Conditions

Antineoplastic Chemotherapy Induced Anemia

Keywords

ChemotherapyAnemiaEpoetin alfaErythropoiesis stimulating agent (ESA)

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events

    Baseline to 12 weeks

Secondary Outcomes (3)

  • Hemoglobin levels and percentage of responders

    Every 4 weeks and 12 weeks

  • Quality of life

    12 Weeks

  • Hemoglobin levels ≥ 2 g/dl

    12 weeks

Study Arms (1)

Open Label

OTHER

One arm open label

Biological: Epoetin alfa

Interventions

Epoetin alfaBIOLOGICAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centro Oncologico de Investigaciones Buenos Aires

Berazategui, Buenos Aires, Argentina

Location

Centro de Medicina Integral e Investigación Clínica

Buenos Aires, Buenos Aires, Argentina

Location

Hospital Zonal Especializado en Oncología de Lanus

Lanús Este, Buenos Aires, CP 1824, Argentina

Location

MeSH Terms

Conditions

Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Roberto Diez, MD

    Bio Sidus SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2011

First Posted

June 16, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

AR(3)