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
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
Observational
Primary Outcome
Correlation of a statistically significant discriminator of sensitivity with complete response rate
Condition
Fallopian Tube Cancer
Intervention
flow cytometry
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
60
Start Date
March 2006
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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Vladimir D. Kravtsov, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00897039
Organization ID
CDR0000491440
Secondary IDs
SEG-20060042
Study Sponsor
Southeastern Gynecologic Oncology
Study Sponsor
Vladimir D. Kravtsov, MD, Study Chair, Pierian Biosciences
Verification Date
July 2009