Recruiting

Observational Study

Sponsor:

Southeastern Gynecologic Oncology

Code:

NCT00897039

Conditions

Fallopian Tube Cancer

Ovarian Cancer

Primary Peritoneal Cavity Cancer

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

flow cytometry

immunohistochemistry staining method

Study Details

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.

Conditions

Fallopian Tube Cancer

Ovarian Cancer

Primary Peritoneal Cavity Cancer

Study ID

NCT00897039

Start date

Mar, 2006

Status verified date

Jul, 2009

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

flow cytometry

immunohistochemistry staining method

Primary outcome measure

  • Correlation of a statistically significant discriminator of sensitivity with complete response rate [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Southeastern Gynecologic Oncology, LLP - Northside

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Clinical Trials Office - Southeastern Gynecologic Oncology, LL

678-420-4154

More Information

Sponsor

Southeastern Gynecologic Oncology

Last update posted

Sep 20, 2013

Last verified

Jul, 2009

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southeastern Gynecologic Oncology on 2013-09-20.