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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pegfilgrastim

Group Type ACTIVE_COMPARATOR

PI Discretion

Intervention Type OTHER

PI Discretion

Placebo

Group Type PLACEBO_COMPARATOR

PI Discretion

Intervention Type OTHER

PI Discretion

Interventions

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PI Discretion

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No