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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Unknown status
Phase
Locations
United States
Study Type
Observational
Intervention
flow cytometry
immunohistochemistry staining method
Sponsored by
Southeastern Gynecologic Oncology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Fallopian Tube Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Southeastern Gynecologic Oncology, LLP - NorthsideRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 9, 2009
Last Updated
September 19, 2013
Sponsor
Southeastern Gynecologic Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00897039
Brief Title
Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Official Title
Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas
Study Type
Observational

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Southeastern Gynecologic Oncology

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
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

7. Study Design

Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Primary Outcome Measure Information:
Title
Correlation of a statistically significant discriminator of sensitivity with complete response rate

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir D. Kravtsov, MD
Organizational Affiliation
Pierian Biosciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Matthew O. Burrell, MD
Organizational Affiliation
Southeastern Gynecologic Oncology
Facility Information:
Facility Name
Southeastern Gynecologic Oncology, LLP - Northside
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Southeastern Gynecologic Oncology, LL
Phone
678-420-4154

12. IPD Sharing Statement

Learn more about this trial

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

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