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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Duration of Grade 4 Neutropenia

Outcome Time Frame:

During treatment

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20030122

NCT ID:

NCT00113789

Start Date:

October 2003

Completion Date:

April 2005

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • topotecan
  • neutropenia
  • Neulasta┬«
  • Ovarian Neoplasms

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