Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer
NCT ID: NCT00217568
Last Updated: 2010-09-21
Study Results
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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COMPLETED
PHASE2
INTERVENTIONAL
2005-05-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.
Detailed Description
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* Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse.
* Determine the response rates (complete and partial response) in patients treated with this regimen.
* Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses.
After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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pegfilgrastim
carboplatin
docetaxel
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
* Stage III or IV disease
* No borderline tumors
* Measurable or evaluable disease
* Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation
* Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)
* In first relapse
* Platinum-sensitive disease, defined as initial relapse \> 6 months after completion of a platinum-based regimen
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
Hepatic
* Bilirubin normal
* Meets 1 of the following criteria:
* SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN
* SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal
Renal
* Creatinine ≤ 2.0 mg/dL
* Creatinine clearance \> 50 mL/min
Cardiovascular
* LVEF ≥ 50%
* No poorly controlled arrhythmia
* No unstable coronary artery disease or myocardial infarction within the past year
Other
* HIV negative
* No pre-existing peripheral neuropathy \> grade 2
* No history of allergy to study drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy
* Not specified
Radiotherapy
* At least 3 weeks since prior radiotherapy and recovered
Surgery
* Recovered from recent prior surgery
Other
* No concurrent myelosuppressive therapy
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Principal Investigators
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Leona A. Holmberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
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Pacific Gynecology Specialists
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
University of Washington School of Medicine
Seattle, Washington, United States
Countries
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Other Identifiers
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PSOC-1702
Identifier Type: -
Identifier Source: secondary_id
AVENTIS-PSOC-1702
Identifier Type: -
Identifier Source: secondary_id
PSOC-IRB-4861
Identifier Type: -
Identifier Source: secondary_id
CDR0000441307
Identifier Type: REGISTRY
Identifier Source: secondary_id
PSOC 1702
Identifier Type: -
Identifier Source: org_study_id