Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2006 |
Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas
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.
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.
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.
- 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.
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
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