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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00897039
• Other study ID #: CDR0000491440
• Secondary ID: SEG-20060042SEG-
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: September 19, 2013
• Start date: March 2006

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Other:
• flow cytometry

• immunohistochemistry staining method

Locations

Country	Name	City	State
United States	Southeastern Gynecologic Oncology, LLP - Northside	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Southeastern Gynecologic Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of a statistically significant discriminator of sensitivity with complete response rate			No