Ovarian Cancer Clinical Trial
Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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.
Full 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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.