Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer

What is the purpose of this trial?

Who can participate?

Ages Eligible: 18 Years and older
Gender Eligible: Female

Inclusion Criteria:

- Patient has been diagnosed with persistent, refractory, or recurrent epithelial
ovarian, peritoneal, or fallopian tube carcinoma.

- Patient must have documented disease defined by physical exam, clinically significant
increases in CA-125 (as defined by protocol), CT, MRI scan, PET, x-ray or ultrasound
for whom cytoreduction, excisional biopsy, incisional biopsy, or paracentesis is
medically indicated, or in the alternative, have agreed to a core biopsy of the
primary site, a secondary metastatic site, or a paracentesis or thoracentesis for
fluid collection.

- Patient has disease of one of the following histologic epithelial cell types: serous
adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,
undifferentiated carcinoma, transitional cell carcinoma, clear cell carcinoma, or
adenocarcinoma, not otherwise specified (N.O.S.). Cytologic confirmation of
diagnosis is acceptable for patients treated with neoadjuvant therapy who have not
had a surgical procedure for a histologic confirmation.

- Patient has only received one or two prior chemotherapy regimens for their ovarian,
peritoneal, or fallopian tube carcinoma. Multiple previous regimens of
Taxol/Carboplatin will be counted as 1 prior chemotherapy regimen (e.g., A patient
who receives first line Taxol/Carboplatin, then recurs, then receives
Taxol/Carboplatin will be considered to have had only 1 prior regimen.)

- Patient must have completed prior chemotherapy regimens at least 3 weeks prior to
tissue extraction.

- Patient must have an estimated life expectancy of greater than six months, as
determined by the investigator.

- Patient requires chemotherapy and the investigator plans to administer one of the
regimens of interest as deemed by her physician.

- Patient must be a female and at least 18 years of age. Ovarian cancer is a disease
that occurs only in women and is exceedingly rare in females under the age of 18.

- Patient must have an ECOG Performance Status of 0, 1, or 2.

- Tumor tissue or ascitic fluid must be available for the assays. Ascites or Pleural
alone may be collected and submitted as the sample tissue, but the patient must also
have measurable disease as demonstrated by a CA-125 level 2X ULN or measurable
lesions on imaging to be eligible.

- Patient must have signed an approved consent form.

Exclusion Criteria:

- Patient has ovarian stromal, mixed mullerian, or germ cell tumors

- Patient has borderline carcinoma (uncertain malignant potential)

- Pregnant or lactating patients

- Patients of childbearing potential not employing adequate contraception.

- Patients who are at risk of failure of compliance to the visit schedules and
procedures.

- The investigator plans to use an assay to select the chemotherapy drug regimen. The
investigator may submit the patient's tissue for testing with other assays, but may
not use the results of those assays to select the chemotherapy regimen for the
patient for this trial.

- Patients with synchronous primary endometrial cancer or a past history of primary
endometrial cancer are excluded unless all of the following conditions are met:
Stage not greater than I-B, Less than 3mm invasion without vascular or lymphatic
invasion, NO poorly differentiated subtype, including papillary serous, clear cell,
or othe FIGO Grade 3 lesion.

What is the purpose of this trial?

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Who can participate?

Ages Eligible: 18 Years and older
Gender Eligible: Female

Inclusion Criteria:

- Patient has been diagnosed with persistent, refractory, or recurrent epithelial
ovarian, peritoneal, or fallopian tube carcinoma.

- Patient must have documented disease defined by physical exam, clinically significant
increases in CA-125 (as defined by protocol), CT, MRI scan, PET, x-ray or ultrasound
for whom cytoreduction, excisional biopsy, incisional biopsy, or paracentesis is
medically indicated, or in the alternative, have agreed to a core biopsy of the
primary site, a secondary metastatic site, or a paracentesis or thoracentesis for
fluid collection.

- Patient has disease of one of the following histologic epithelial cell types: serous
adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,
undifferentiated carcinoma, transitional cell carcinoma, clear cell carcinoma, or
adenocarcinoma, not otherwise specified (N.O.S.). Cytologic confirmation of
diagnosis is acceptable for patients treated with neoadjuvant therapy who have not
had a surgical procedure for a histologic confirmation.

- Patient has only received one or two prior chemotherapy regimens for their ovarian,
peritoneal, or fallopian tube carcinoma. Multiple previous regimens of
Taxol/Carboplatin will be counted as 1 prior chemotherapy regimen (e.g., A patient
who receives first line Taxol/Carboplatin, then recurs, then receives
Taxol/Carboplatin will be considered to have had only 1 prior regimen.)

- Patient must have completed prior chemotherapy regimens at least 3 weeks prior to
tissue extraction.

- Patient must have an estimated life expectancy of greater than six months, as
determined by the investigator.

- Patient requires chemotherapy and the investigator plans to administer one of the
regimens of interest as deemed by her physician.

- Patient must be a female and at least 18 years of age. Ovarian cancer is a disease
that occurs only in women and is exceedingly rare in females under the age of 18.

- Patient must have an ECOG Performance Status of 0, 1, or 2.

- Tumor tissue or ascitic fluid must be available for the assays. Ascites or Pleural
alone may be collected and submitted as the sample tissue, but the patient must also
have measurable disease as demonstrated by a CA-125 level 2X ULN or measurable
lesions on imaging to be eligible.

- Patient must have signed an approved consent form.

Exclusion Criteria:

- Patient has ovarian stromal, mixed mullerian, or germ cell tumors

- Patient has borderline carcinoma (uncertain malignant potential)

- Pregnant or lactating patients

- Patients of childbearing potential not employing adequate contraception.

- Patients who are at risk of failure of compliance to the visit schedules and
procedures.

- The investigator plans to use an assay to select the chemotherapy drug regimen. The
investigator may submit the patient's tissue for testing with other assays, but may
not use the results of those assays to select the chemotherapy regimen for the
patient for this trial.

- Patients with synchronous primary endometrial cancer or a past history of primary
endometrial cancer are excluded unless all of the following conditions are met:
Stage not greater than I-B, Less than 3mm invasion without vascular or lymphatic
invasion, NO poorly differentiated subtype, including papillary serous, clear cell,
or othe FIGO Grade 3 lesion.

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