Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
NCT ID: NCT00897039
Last Updated: 2013-09-20
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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UNKNOWN
60 participants
OBSERVATIONAL
2006-03-31
Brief Summary
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PURPOSE: This laboratory study is looking at tumor tissue samples to predict response to chemotherapy in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
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Detailed Description
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* Evaluate the ability of the microculture kinetic (MiCK) assay to predict the outcome of patients with ovarian, fallopian tube, or primary peritoneal adenocarcinoma treated with first-line chemotherapy.
* Evaluate the ability of the MiCK assay to guide chemotherapy in a third-line, refractory treatment setting (exclusive of anti-vascular endothelial growth factor) in these patients.
OUTLINE: Patients are stratified according to prior chemotherapy (no \[stratum I\] vs yes \[stratum II\]).
Tumor tissue and/or effusion specimens are collected at baseline. Specimens are examined by the microculture kinetic (MiCK) assay and immunocytochemical or flow cytometry assay.
MiCK assay results do not influence treatment for stratum I patients. Stratum II patients may receive treatment based on MiCK assay results for tumor sensitivity to specific chemotherapy drugs.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Conditions
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Interventions
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flow cytometry
immunohistochemistry staining method
Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed adenocarcinoma of 1 of the following types:
* Ovarian
* Primary peritoneal
* Fallopian tube
* Must meet 1 of the following criteria:
* De novo malignancy with no prior chemotherapy
* Advanced refractory malignancy with ≤ 2 standard chemotherapy treatment protocols
* Tumor must be accessible for biopsy or drainage of effusions
* Chemotherapy is considered a treatment option
* No symptomatic or uncontrolled parenchymal brain metastases
* No meningeal metastasis
PATIENT CHARACTERISTICS:
* Not pregnant
* Negative pregnancy test
* Fertile patients must agree to use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
FEMALE
No
Sponsors
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Southeastern Gynecologic Oncology
OTHER
Principal Investigators
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Vladimir D. Kravtsov, MD
Role: STUDY_CHAIR
Pierian Biosciences
Matthew O. Burrell, MD
Role:
Southeastern Gynecologic Oncology
Locations
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Southeastern Gynecologic Oncology, LLP - Northside
Atlanta, Georgia, United States
Countries
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Facility Contacts
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Clinical Trials Office - Southeastern Gynecologic Oncology, LL
Role: primary
Other Identifiers
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SEG-20060042
Identifier Type: -
Identifier Source: secondary_id
SEG-IRB-1075624
Identifier Type: -
Identifier Source: secondary_id
CDR0000491440
Identifier Type: -
Identifier Source: org_study_id
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