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Protein Evaluation in Patients With Stage III or Stage IV Primary Peritoneal or Fallopian Tube Cancer or Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer in Remission
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020033
  Purpose

RATIONALE: The presence of specific proteins may allow a doctor to determine whether or not cancer has relapsed.

PURPOSE: This clinical trial is studying how well protein evaluation predicts disease relapse in patients with stage III or stage IV primary peritoneal or fallopian tube cancer or stage II, stage III, or stage IV ovarian epithelial cancer that is in remission.


Condition Intervention
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Procedure: diagnostic imaging
Procedure: laboratory biomarker analysis
Procedure: proteomic profiling
Procedure: surface-enhanced laser desorption/ionization-time of flight mass spectrometry

MedlinePlus related topics: Cancer Ovarian Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: A Pilot Study of Proteomic Evaluation of Epithelial Ovarian Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile Associated With Relapse

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Create serum and body fluid proteomic profiling by surface-enhanced laser desorption and ionization with time-of-flight detection (SELDI-TOF) and artificial intelligence at baseline, 1 mo., and then every 3 mo. [ Designated as safety issue: No ]
  • Sensitivity and specificity of the serum proteomic signature profiles measured by SELDI-TOF and artificial intelligence at baseline, 1 month, and then every 3 months [ Designated as safety issue: No ]
  • Sensitivity & specificity of proteomic signature profiles of serum, body fluid and tumor biopsy compared with CA-125 serum tumor marker profiles by SELDI-TOF & artificial intelligence and serum CA-125 at baseline, 1 mo. and then every 3 mo. [ Designated as safety issue: No ]

Study Start Date: June 2000
Detailed Description:

OBJECTIVES:

  • Create serum and body fluid protein profiles of patients with stage III or IV primary peritoneal, fallopian tube, or ovarian epithelial cancer, or stage IIC ovarian clear cell cystadenocarcinoma in first remission through relapse.
  • Analyze expressed protein profiles to try to identify a pattern or changes in patterns associated with relapse in this patient population.
  • Compare expressed protein profiles in blood and body fluids at relapse with expressed protein patterns in tumor relapse specimen of these patients.
  • Determine the associative/predictive value of serum lysophosphatidic acid measurements for ovarian cancer relapse.

OUTLINE: Patients undergo history, physical examination with pelvic examination, laboratory evaluation, and noninvasive imaging at baseline, 1 month, 3 months, and every 3 months thereafter. Samples are analyzed by surface enhanced laser desorption ionization spectrometry to identify protein profiles. Samples are also analyzed for lysophosphatidic acid. Patient evaluation continues until biopsy proven relapse.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV primary peritoneal, fallopian tube, or ovarian epithelial cancer, or stage IIC ovarian clear cell cystadenocarcinoma in first clinical remission as defined by:

    • Normal CA-125
    • Normal physical exam
    • Normal post-hysterectomy pelvic examination
    • No evidence of disease on CT scan or other noninvasive reassessment
  • No nonepithelial or mixed epithelial/nonepithelial ovarian cancer
  • Completion of standard platinum/paclitaxel or carboplatin/paclitaxel-based chemotherapy with complete response

    • No more than 9 weeks since final course of chemotherapy or triple therapy (no more than 12 weeks since final dose of chemotherapy)

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy, including replacement hormonal therapy

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • No concurrent surgery

Other:

  • No concurrent alternative therapy
  • No other concurrent cancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020033

Locations
United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892-1906
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Virginia Kwitkowski, MS, RN, CS, CRNP National Cancer Institute (NCI)
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000067598, NCI-00-C-0018
Study First Received: July 11, 2001
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00020033  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
ovarian clear cell cystadenocarcinoma
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Ovarian cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms
Fallopian Tube Neoplasms
Dental Caries
Fallopian Tube Diseases
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Fallopian tube cancer
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009