Clinical trial · Interventional

An Efficacy and Safety Study of Epoetin Alfa (PROCRIT) Initiated at 40,000 Units Every Week Versus 80,000 Units Every Two Weeks in Anemic Patients With Cancer Receiving Chemotherapy.

A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Initiated At 40,000 Units Every Week Versus 80,000 Units Every Two Weeks In Anemic Patients With Cancer Receiving Chemotherapy

NCT00210834CI-TRIAL-00005003completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The primary objective of this study is to compare end of study hemoglobin levels between Epoetin alfa at 40,000 units administered subcutaneously once every week and at 80,000 units subcutaneously every two weeks in anemic patients with cancer receiving chemotherapy. The secondary objectives of the study are to assess the Hb response, time to Hb response, transfusion requirements, and safety.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Anemia	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
epoetin alfa	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

[]

Primary outcomes (1)

measure
The end of study Hb. The end of study Hb is defined as the patient's final Hb level, taken 2 weeks after the last dose of PROCRIT or at Week 13, whichever comes first.

Secondary outcomes (1)

measure
Time to 1 g/dL HB increase; Proportion of patients achieving a >= 1 g/dL Hb increase by week for Weeks 5-13; Time to Hb increase of 2 g/dL or achieving Hb of >= 12 g/dL; Proportion of patients achieving a >= 2 g/dL Hb increase or Hb of 12 g/dL by EOS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Histologically confirmed diagnosis of non-myeloid malignancy
* Baseline hemoglobin value of \<= 11 g/dL unrelated to transfusion
* Planned chemotherapy for a minimum of 12 weeks during the study
* Life expectancy of \>= 6 months
* ECOG Performance Status 0-2

Exclusion Criteria:

* Diagnosis of a myeloid malignancy or known history of myelodysplasia
* Planned non-palliative radiation during the study
* Anemia due to factors other than cancer/chemotherapy
* Prior treatment with Epoetin alfa or any other erythropoietic agent within the previous three months
* History of uncontrolled cardiac arrhythmias or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder

References

Publications (1)

RESULTHenry DH, Gordan LN, Charu V, Wilhelm FE, Williams D, Xie J, Woodman RC. Randomized, open-label comparison of epoetin alfa extended dosing (80 000 U Q2W) vs weekly dosing (40 000 U QW) in patients with chemotherapy-induced anemia. Curr Med Res Opin. 2006 Jul;22(7):1403-13. doi: 10.1185/030079906X115559. PMID 16834839