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


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Clinical Trial: Evaluating Pegfilgrastim and a Multi-Day Topotecan Regimen in Subjects with Relapsed or Refractory Ovarian Cancer

This study is no longer recruiting patients.

Sponsored by: Amgen
Information provided by: Amgen

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
 Drug: Pegfilgrastim
Phase II

MedlinePlus related topics:  Ovarian Cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Safety/Efficacy Study

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

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female
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)

More Information

Study ID Numbers:  20030122
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 10, 2005
ClinicalTrials.gov Identifier:  NCT00113789
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05

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December 4, 2008



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