A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse)
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/6/2019 |
| Start Date: | November 17, 1999 |
A Pilot Study of Proteomic Evaluation of Epithelial Ovarian Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile Associated With Relapse
Every cell in the human body contains hundreds of thousands of genes and the proteins made by
the genes. Sometimes changes take place in the genes or proteins that may make the cells more
likely to develop into cancer. An experimental protein profile test that finds these changes
may be able to provide information about whose cancer will stay in remission and whose will
return.
Volunteer patients whose epithelial ovarian cancer is in remission are eligible for this
study. Specimens will be collected from blood, saliva, and urine for the first protein
profile test. Sample sets for more protein profile tests will be collected at follow-up
visits 1 month and 3 months later and every 3 months afterward. If and when the cancer
returns, an additional sample set will be obtained and a biopsy of the relapsed tumor will be
taken both for a protein profile test and for review of the function and structure of the
disease (pathology review). The protein profiles from these samples will be compared to those
samples already collected to detect protein pattern changes. The amount of lysophosphatidic
acid (LPA) in the blood, a sign of ovarian cancer, will also be measured to see if LPA is
useful in detecting the return of ovarian cancer.
If patients get fluid in the stomach or chest, it will be tested for cancer cells and
proteins made by the tumor. If a physical exam or CT scan indicates a possible return of the
cancer, a biopsy will be performed and a sample saved for a protein profile.
the genes. Sometimes changes take place in the genes or proteins that may make the cells more
likely to develop into cancer. An experimental protein profile test that finds these changes
may be able to provide information about whose cancer will stay in remission and whose will
return.
Volunteer patients whose epithelial ovarian cancer is in remission are eligible for this
study. Specimens will be collected from blood, saliva, and urine for the first protein
profile test. Sample sets for more protein profile tests will be collected at follow-up
visits 1 month and 3 months later and every 3 months afterward. If and when the cancer
returns, an additional sample set will be obtained and a biopsy of the relapsed tumor will be
taken both for a protein profile test and for review of the function and structure of the
disease (pathology review). The protein profiles from these samples will be compared to those
samples already collected to detect protein pattern changes. The amount of lysophosphatidic
acid (LPA) in the blood, a sign of ovarian cancer, will also be measured to see if LPA is
useful in detecting the return of ovarian cancer.
If patients get fluid in the stomach or chest, it will be tested for cancer cells and
proteins made by the tumor. If a physical exam or CT scan indicates a possible return of the
cancer, a biopsy will be performed and a sample saved for a protein profile.
Over 80 percent of advanced stage epithelial cancer patients relapse after attaining first
clinical remission with standard platinum/paclitaxel-based chemotherapy. Surrogate biomarkers
are needed for the evaluation of efficacy of treatment and for use as predictors of disease
in screening and for relapse diagnosis. CA-125, the existing ovarian cancer marker, will
become elevated with relapse in some but not all of the 80 percent of patients for whom it
was increased at initial diagnosis. Elevation in CA-125 may precede clinical evidence of
relapse by as much as 6 - 10 months or lag behind clinical relapse by the same time
intervals, making it a less than satisfactory clinical tool. Emerging proteomic technologies
allow for scanning of cellular proteins in a simple, short, reproducible, and quantitative
chemical assay. We hypothesize that changes in a patient s protein pattern will be detectable
and will be reliably associated with relapse. This protocol is a pilot study for our ability
to ascertain and evaluate samples from ovarian cancer patients followed in first clinical
remission, and investigate whether analysis of sequential protein fingerprints will yield a
reproducible pattern of change that may be associated with relapse.
clinical remission with standard platinum/paclitaxel-based chemotherapy. Surrogate biomarkers
are needed for the evaluation of efficacy of treatment and for use as predictors of disease
in screening and for relapse diagnosis. CA-125, the existing ovarian cancer marker, will
become elevated with relapse in some but not all of the 80 percent of patients for whom it
was increased at initial diagnosis. Elevation in CA-125 may precede clinical evidence of
relapse by as much as 6 - 10 months or lag behind clinical relapse by the same time
intervals, making it a less than satisfactory clinical tool. Emerging proteomic technologies
allow for scanning of cellular proteins in a simple, short, reproducible, and quantitative
chemical assay. We hypothesize that changes in a patient s protein pattern will be detectable
and will be reliably associated with relapse. This protocol is a pilot study for our ability
to ascertain and evaluate samples from ovarian cancer patients followed in first clinical
remission, and investigate whether analysis of sequential protein fingerprints will yield a
reproducible pattern of change that may be associated with relapse.
- INCLUSION CRITERIA
All patients in first clinical remission from treatment of FIGO stage III/IV primary
peritoneal, fallopian tube, or epithelial ovarian carcinoma or stage IIC clear cell
histology epithelial ovarian cancer 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.
Entry within 9 weeks of completion of final cycle of chemotherapy (within 12 weeks of last
administration of chemotherapy).
S/P completion of primary therapy with standard platinum/paclitaxel or
carboplatin/paclitaxel-containing chemotherapy and in confirmed clinical complete response.
At least one block from the primary tumor must be received. (If available, a sample of
frozen primary tumor should also be forwarded).
ECOG performance status of 0, 1, or 2.
EXCLUSION CRITERIA
Patients with nonepithelial ovarian cancer, or mixed epithelial/nonepithelial ovarian
cancer.
Patients may not be receiving chemotherapy, hormonal therapy, alternative therapy, or
radiation therapy. No therapy of any kind is allowed while the patient is on-study.
Replacement hormonal therapy is not allowed.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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