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: July 13, 2011

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

July 13, 2011

Start Date ^ICMJE

March 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Correlation of a statistically significant discriminator of sensitivity with complete response rate [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00897039 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed 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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer

Intervention ^ICMJE

Other: flow cytometry
Other: immunohistochemistry staining method

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00897039

Other Study ID Numbers ^ICMJE

CDR0000491440, SEG-20060042, SEG-IRB-1075624

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Southeastern Gynecologic Oncology, LLP - Northside

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Vladimir D. Kravtsov, MD	DiaTech Oncology
Investigator:	Matthew O. Burrell, MD	Southeastern Gynecologic Oncology, LLP - Northside

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

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

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