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
Recruitment status was Recruiting
Sponsor:
Southeastern Gynecologic Oncology, LLP - Northside
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer |
Other: flow cytometry Other: immunohistochemistry staining method |
| Study Type: | Observational |
| Official Title: | Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Correlation of a statistically significant discriminator of sensitivity with complete response rate [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2006 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897039
Locations
| United States, Georgia | |
| Southeastern Gynecologic Oncology, LLP - Northside | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Clinical Trials Office - Southeastern Gynecologic Oncology, LL 678-420-4154 | |
Sponsors and Collaborators
Southeastern Gynecologic Oncology, LLP - Northside
Investigators
| Study Chair: | Vladimir D. Kravtsov, MD | DiaTech Oncology |
| Investigator: | Matthew O. Burrell, MD | Southeastern Gynecologic Oncology, LLP - Northside |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00897039 History of Changes |
| Other Study ID Numbers: | CDR0000491440, SEG-20060042, SEG-IRB-1075624 |
| Study First Received: | May 9, 2009 |
| Last Updated: | July 13, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Adenocarcinoma Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases |
ClinicalTrials.gov processed this record on May 19, 2013