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


N/A
N/A
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Correlation of a statistically significant discriminator of sensitivity with complete response rate

Safety Issue:

No

Principal Investigator

Vladimir D. Kravtsov, MD

Investigator Role:

Study Chair

Investigator Affiliation:

DiaTech Oncology

Authority:

Unspecified

Study ID:

CDR0000491440

NCT ID:

NCT00897039

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • ovarian serous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • recurrent ovarian epithelial cancer
  • ovarian clear cell cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • stage IA ovarian epithelial cancer
  • stage IB ovarian epithelial cancer
  • stage IC ovarian epithelial cancer
  • stage IIA ovarian epithelial cancer
  • stage IIB ovarian epithelial cancer
  • stage IIC ovarian epithelial cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • recurrent primary peritoneal cavity cancer
  • stage IA primary peritoneal cavity cancer
  • stage IB primary peritoneal cavity cancer
  • stage IC primary peritoneal cavity cancer
  • stage IIA primary peritoneal cavity cancer
  • stage IIB primary peritoneal cavity cancer
  • stage IIC primary peritoneal cavity cancer
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIIC primary peritoneal cavity cancer
  • recurrent fallopian tube cancer
  • stage IA fallopian tube cancer
  • stage IB fallopian tube cancer
  • stage IC fallopian tube cancer
  • stage IIA fallopian tube cancer
  • stage IIB fallopian tube cancer
  • stage IIC fallopian tube cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • Adenocarcinoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Southeastern Gynecologic Oncology, LLP - NorthsideAtlanta, Georgia  30342