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 because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897039
First received: May 9, 2009
Last updated: September 19, 2013
Last verified: July 2009

May 9, 2009
September 19, 2013
March 2006
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Correlation of a statistically significant discriminator of sensitivity with complete response rate [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00897039 on ClinicalTrials.gov Archive Site
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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
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  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Other: flow cytometry
  • Other: immunohistochemistry staining method
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
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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
Female
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No
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United States
 
NCT00897039
CDR0000491440, SEG-20060042, SEG-IRB-1075624
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Southeastern Gynecologic Oncology, LLP - Northside
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Study Chair: Vladimir D. Kravtsov, MD DiaTech Oncology
Investigator: Matthew O. Burrell, MD Southeastern Gynecologic Oncology, LLP - Northside
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP