Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00113789
First received: June 10, 2005
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Other: PI Discretion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Duration of Grade 4 Neutropenia [ Time Frame: During treatment ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: October 2003
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pegfilgrastim Other: PI Discretion
PI Discretion
Placebo Comparator: Placebo Other: PI Discretion
PI Discretion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Subjects with histologically confirmed primary peritoneal carcinoma, epithelial ovarian cancer, or tubal carcinoma relapsed after or refractory to 1 or 2 prior regimens of therapy - Measurable or evaluable disease - GOG Performance Status of 0 to 2 - Subjects must be at least 2 weeks from major surgery and recovered from all associated toxicities or sequelae - At least 2 weeks from radiation therapy and recovered from all associated toxicities - Adequate hemopoietic function evidenced by: *ANC greater than 1.5 x 10^9/L, *platelets greater than 100 x 10^9/L and *hemoglobin greater than or equal to 10 g/dL - AST and ALT less than 1.5 x ULN; total serum bilirubin less than or equal to 2.0 mg/dL; serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than or equal to 60 mL/min Exclusion Criteria: - Epithelial ovarian tumors of low malignant potential - Prior therapy with topotecan - Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of chemotherapy - Prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, and/or carcinoma of the cervix in-situ - History of impaired cardiac status (e.g., severe heart disease, cardiomyopathy, or congestive heart failure) - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukemia - Subject is pregnant (e.g., positive HCG test) or breast feeding - Subject is of child-bearing potential and does not agree to using adequate contraceptive precautions - Any psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with study protocol procedures - Other investigational procedures are excluded. Subject is currently enrolled in, or has not yet completed at least 30 days since ending another investigational device or drug trial(s) or is receiving other investigational agent(s)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113789

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00113789     History of Changes
Other Study ID Numbers: 20030122
Study First Received: June 10, 2005
Last Updated: February 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
ovarian cancer
topotecan
neutropenia
Neulasta®

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Topotecan
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014