NCT00113789CompletedPhase 2
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
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 21
- Primary Endpoint
- Duration of Grade 4 Neutropenia
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Duration of Grade 4 Neutropenia
Time Frame: During treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
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