Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Sponsor

Southeastern Gynecologic Oncology (Other)

Overall Status

Unknown status

CT.gov ID

NCT00897039

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer	Other: flow cytometry Other: immunohistochemistry staining method

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Official Title:

Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas

Study Start Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

Correlation of a statistically significant discriminator of sensitivity with complete response rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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