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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00138242 |
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Date of registration:
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29/08/2005 |
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Primary sponsor: |
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Public title:
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Docetaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
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Scientific title:
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Phase II Trial of Weekly Docetaxel (Taxotere®) and Carboplatin as Initial Chemotherapy for Women With Ovarian Cancer and Similar Malignancies |
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Date of first enrolment:
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December 2004 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00138242 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Howard G. Muntz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal cavity
cancer
- Stage IC-IV disease
- No borderline or low malignant potential tumors of any stage
- Underwent initial surgical management, including staging, of early stage disease or
surgical debulking of advanced stage disease* NOTE: *Patients may delay surgical
debulking, if clinically indicated, until after study entry; these patients may
receive several courses of neoadjuvant chemotherapy prior to surgical debulking, but
before study entry
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count = 1,500/mm^3
- Hemoglobin = 8.0 g/dL
- Platelet count = 100,000/mm^3
Hepatic
- Bilirubin normal
- Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST or ALT = 5 times upper limit of normal
(ULN)
- AP = 2.5 times ULN AND AST or ALT = 1.5 times ULN
- AP = 5 times ULN AND AST or ALT normal
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for = 3 months after
completion of study treatment
- No peripheral neuropathy > grade 1
- No prior malignancy with a poor prognosis that is at risk of relapse during study
participation, as determined by the principal investigator
- No history of severe hypersensitivity reaction to drugs formulated with polysorbate
80
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No concurrent chemotherapy for another malignancy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Fallopian Tube Cancer
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Ovarian Cancer
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Primary Peritoneal Cavity Cancer
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Intervention(s)
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Drug: carboplatin
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Drug: docetaxel
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Procedure: adjuvant therapy
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Primary Outcome(s)
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Reduction rate of myelosuppression
[Time Frame: No]
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Secondary Outcome(s)
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Clinical response rate
[Time Frame: No]
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Findings at second look surgery
[Time Frame: No]
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Quality of life as assessed by the Functional Assessment of Cancer Therapy -Ovarian (FACT-O) questionnaire
[Time Frame: No]
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Time to disease progression
[Time Frame: No]
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Toxicity
[Time Frame: Yes]
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Secondary ID(s)
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AVENTIS-VMRC-8837
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CDR0000439927
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VMRC-8837
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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