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OpenTrials
Completed

NCT Number: NCT00121030

Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy

The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in gynecological cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.

Completed

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Key information

Conditions

Gynecological Malignancies Adnexal Diseases Anemia Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Subjects receiving multi-cycle chemotherapy for gynecological cancer - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Known positive test for human immunodeficiency virus (HIV) infection

Treatment and study plan

darbepoetin alfa

Drug

recombinant human erythropoietin (rHuEPO)

Drug

Primary outcomes

  1. Anemia correction

Secondary outcomes

  1. Patient preference

  2. Activities of daily living

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patients With Gynecological Malignancies Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy

Important dates

Study start
2002
Study completion
2003
First posted
Jul 21, 2005
Registry last updated
Dec 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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