Clinical trial · Interventional

A Safety Study of Epoetin Alfa in Patients With Cancer Who Have Chemotherapy-Related Anemia

A Randomized, Open-Label, Multicenter Study Evaluating Thrombovascular Events in Subjects With Cancer Receiving Chemotherapy and Administered Epoetin Alfa Once or Three Times a Week for the Treatment of Anemia

NCT01394991CI-TRIAL-00006669completedPhase 4Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer who have chemotherapy-related anemia.

Conditions

Conditions (2)

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	—
Neoplasms	Neoplasm	ONTOLOGY_EXACT	0.90

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Epoetin alfa 150 IU/kg 3 times a week	Drug	—	UNRESOLVED
Epoetin alfa 150 IU/kg 3 times a week (TIW)	Drug	—	UNRESOLVED
Epoetin alfa 450 IU/kg once a week	Drug	—	UNRESOLVED
Epoetin alfa 450 IU/kg once a week (QW)	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
001
description
Epoetin alfa 450 IU/kg once a week (QW) 450 IU/kg once a week (QW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks
interventionNames
1. Drug: Epoetin alfa 450 IU/kg once a week
2. Drug: Epoetin alfa 450 IU/kg once a week (QW)
type
EXPERIMENTAL
label
002
description
Epoetin alfa 150 IU/kg 3 times a week (TIW) 150 IU/kg 3 times a week (TIW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.
interventionNames
1. Drug: Epoetin alfa 150 IU/kg 3 times a week
2. Drug: Epoetin alfa 150 IU/kg 3 times a week (TIW)

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Any nonmyeloid tumor confirmed by cytology and/or histology
* Day 1 baseline hemoglobin (Hb) level \<=11 g/dL
* Expected to receive at least 12 weeks of chemotherapy after enrollment into the study
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2

Exclusion Criteria:

* History of active second cancer except for adequately treated skin cancer and in situ (pre-invasive) cervical cancer
* History of deep venous thrombosis (DVT) (blood clots in the veins of the thighs or legs) or pulmonary embolism (PE) (blood clot in the lungs) within 12 months before study entry or at any time if the event is related to the current cancer, which is defined as diagnosis of the cancer within 3 months of a DVT/PE episode or a DVT/PE following the cancer diagnosis/treatment
* History of cardiovascular accident (CVA), transient ischemic attack (TIA) (stroke), acute coronary syndrome (ACS) (a condition indicating damage to the heart), or other arterial thrombosis (blood clots) within 6 months before study entry
* Onset of seizures within 3 months before randomization or poorly controlled seizures
* Brain tumor or brain metastasis from another malignancy or cardiac disease that is markedly or completely limiting, uncontrolled hypertension (high blood pressure), or anemia (a lack of red blood cells in the blood) for reasons other than cancer or chemotherapy
* Specifically excluded concomitant medications or therapies including prophylactic anticoagulation therapy for recurrence of prior thrombovascular event (TVE) (warfarin, unfractionated heparin, low molecular weight heparin \[LMWH\], except for prevention of central venous catheter thrombosis at doses specified in the protocol, direct thrombin inhibitors, or anti-platelet drugs \[e.g., clopidogrel or ticlopidine\]), except for prophylaxis in patients with known cardiovascular disease

References

Publications (0)

Data not yet available

No reference posted for this study.