Atlanta, Georgia 30342

  • Primary Peritoneal Cavity Cancer

Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00897039


Primary Contact:

Study Chair
Vladimir D. Kravtsov, MD
DiaTech Oncology


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30342
United States

Clinical Trials Office - Southeastern Gynecologic Oncology, LL
Phone: 678-420-4154

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

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