We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00897039
First Posted: May 12, 2009
Last Update Posted: September 20, 2013
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.
Information provided by:
National Cancer Institute (NCI)
May 9, 2009
May 12, 2009
September 20, 2013
March 2006
Not Provided
Correlation of a statistically significant discriminator of sensitivity with complete response rate
Same as current
Complete list of historical versions of study NCT00897039 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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.

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.

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Other: flow cytometry
  • Other: immunohistochemistry staining method
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Not Provided
Not Provided

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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00897039
CDR0000491440
SEG-20060042
SEG-IRB-1075624
Not Provided
Not Provided
Not Provided
Not Provided
Southeastern Gynecologic Oncology
Not Provided
Study Chair: Vladimir D. Kravtsov, MD Pierian Biosciences
Investigator: Matthew O. Burrell, MD Southeastern Gynecologic Oncology
National Cancer Institute (NCI)
July 2009