Clinical Trials Directory

Trials / Unknown

UnknownNCT00897039

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Southeastern Gynecologic Oncology · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERflow cytometry
OTHERimmunohistochemistry staining method

Timeline

Start date
2006-03-01
First posted
2009-05-12
Last updated
2013-09-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00897039. Inclusion in this directory is not an endorsement.