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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00897039
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 12, 2009
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Other: flow cytometry Other: immunohistochemistry staining method

Detailed Description:


  • 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.

Study Type : Observational
Estimated Enrollment : 60 participants
Official Title: Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas
Study Start Date : March 2006

Primary Outcome Measures :
  1. Correlation of a statistically significant discriminator of sensitivity with complete response rate

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must agree to use effective contraception


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00897039

United States, Georgia
Southeastern Gynecologic Oncology, LLP - Northside Recruiting
Atlanta, Georgia, United States, 30342
Contact: Clinical Trials Office - Southeastern Gynecologic Oncology, LL    678-420-4154      
Sponsors and Collaborators
Southeastern Gynecologic Oncology
Study Chair: Vladimir D. Kravtsov, MD Pierian Biosciences
OverallOfficial: Matthew O. Burrell, MD Southeastern Gynecologic Oncology Identifier: NCT00897039     History of Changes
Other Study ID Numbers: CDR0000491440
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases