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

Southeastern Gynecologic Oncology

Status: Unknown

Conditions: Primary Peritoneal Cavity Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Other: flow cytometry; Other: immunohistochemistry staining method

Study type: Observational

Funder types: Other

Identifiers

NCT00897039

CDR0000491440

SEG-20060042

SEG-IRB-1075624

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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