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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

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

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Brief Summary

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RATIONALE: Collecting samples of tissue from patients with cancer to study in the laboratory may help doctors predict how well patients will respond to treatment with certain chemotherapy drugs and plan the best treatment.

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.

Detailed Description

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OBJECTIVES:

* 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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Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer

Keywords

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ovarian serous cystadenocarcinoma ovarian undifferentiated adenocarcinoma recurrent ovarian epithelial cancer ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mucinous cystadenocarcinoma stage IA ovarian epithelial cancer stage IB ovarian epithelial cancer stage IC ovarian epithelial cancer stage IIA ovarian epithelial cancer stage IIB ovarian epithelial cancer stage IIC ovarian epithelial cancer stage IIIA ovarian epithelial cancer stage IIIB ovarian epithelial cancer stage IIIC ovarian epithelial cancer recurrent primary peritoneal cavity cancer stage IA primary peritoneal cavity cancer stage IB primary peritoneal cavity cancer stage IC primary peritoneal cavity cancer stage IIA primary peritoneal cavity cancer stage IIB primary peritoneal cavity cancer stage IIC primary peritoneal cavity cancer stage IIIA primary peritoneal cavity cancer stage IIIB primary peritoneal cavity cancer stage IIIC primary peritoneal cavity cancer recurrent fallopian tube cancer stage IA fallopian tube cancer stage IB fallopian tube cancer stage IC fallopian tube cancer stage IIA fallopian tube cancer stage IIB fallopian tube cancer stage IIC fallopian tube cancer stage IIIA fallopian tube cancer stage IIIB fallopian tube cancer stage IIIC fallopian tube cancer

Interventions

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flow cytometry

Intervention Type OTHER

immunohistochemistry staining method

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* 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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Southeastern Gynecologic Oncology

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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United States

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