Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Blood and Lymph Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Neutropenia

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Granulocytopenia

Antineoplastic Agents

All Drugs and Chemicals

Topotecan

PI Discretion

This trial will provide data on the safety and efficacy of pegfilgrastim, in terms of duration of grade 4 neutropenia, when administered on the last day or the day after a multi-day, myelosuppressive chemotherapy regimen for ovarian cancer.

Evaluating Pegfilgrastim and a Multi-Day Topotecan Regimen in Subjects With Relapsed or Refractory Ovarian Cancer

Randomized, Phase 2 Study of Pegfilgrastim Given on the Last Day of a Multi-Day Topotecan Regimen or the Day After in Subjects With Relapsed or Refractory Ovarian Cancer

Amgen

Global Development Leader

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Docetaxel

Carboplatin

The purpose of this research study is to evaluate the safety and effectiveness of Neulasta® (pegfilgrastim) in reducing infection when given on the same day versus one day after the completion of chemotherapy (docetaxel and carboplatin) in patients with advanced or metastatic non-small cell lung cancer (NSCLC). This study is considered to be "investigational" because previous studies with Neulasta® used next day dosing and not same day dosing.

Pegfilgrastim Given Same Day As or Day After Carboplatin and Docetaxel in Advanced Metastatic Non-Small Cell Lung Cancer (NSCLC)

Pegfilgrastim Given Same Day as or Day After Carboplatin and Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

The purpose of the study is to assess the impact of first and subsequent cycle pegfilgrastim on neutropenia events (such as hospitalizations, dose reductions and delays) in patients receiving myelosuppressive chemotherapy.

FIRST - Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy

A Multicenter, Open-label, Phase 4 Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating Pegfilgrastim and a Multi-Day Topotecan Regimen in Subjects With Relapsed or Refractory Ovarian Cancer	NCT00113789	Ovarian Cancer	PI Discretion	18 Years -	Amgen
Evaluating Pegfilgrastim and a Multi-Day Topotecan Regimen in Subjects With Relapsed or Refractory Ovarian Cancer	NCT00113789	Ovarian Cancer	PI Discretion	18 Years -	Amgen
Pegfilgrastim Given Same Day As or Day After Carboplatin and Docetaxel in Advanced Metastatic Non-Small Cell Lung Cancer (NSCLC)	NCT00094822	Lung Cancer Non-Small Cell ...	PI Discretion	18 Years -	Amgen
FIRST - Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy	NCT00125723	Neutropenia	PI Discretion	18 Years -	Amgen
Pegfilgrastim Given Same Day As or Day After Carboplatin and Docetaxel in Advanced Metastatic Non-Small Cell Lung Cancer (NSCLC)	NCT00094822	Lung Cancer Non-Small Cell ...	PI Discretion	18 Years -	Amgen
Pegfilgrastim Given Same Day As or Day After Carboplatin and Docetaxel in Advanced Metastatic Non-Small Cell Lung Cancer (NSCLC)	NCT00094822	Lung Cancer Non-Small Cell ...	PI Discretion	18 Years -	Amgen

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