Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas

Completed · Phase 2/Phase 3

Conditions studied: Adenocarcinoma, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms

In brief

2.0 Study Objectives: 2.1 To evaluate the ability of the MiCK assay to predict the outcome of chemotherapy of cancer patients for first-line treatment. 2.2 To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients in a third-line, refractory treatment setting (exclusive of anti-VEGF)

Key facts

Study ID

NCT00443196

Run by

Pierian Biosciences

People needed

150

Starts

2006-03-01

Expected to finish

2010-09-01

Last updated by the study team

2018-03-12

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with pathological diagnoses of ovarian, fallopian and primary peritoneal adenocarcinomas.
• Patients with de novo malignancies and no previous chemotherapy
• Patients with advanced refractory malignancies who received no more than 2 standard chemotherapy treatment protocols.
• Patients of any age group.
• Patients must have tumor which is accessible and agree to undergo biopsies, or drainage of effusions.
• Patients for whom chemotherapy is a treatment option.
• Explanations: We anticipate that newly diagnosed patients will be mostly used to evaluate the ability of the MiCK assay to predict the outcome of the chemotherapy (Objective #2.1) and to establish criteria correlating numerical response in the MiCK assay with probability of the clinically established complete remission. The patients with refractory malignancies will be mostly used to evaluate the ability of the MiCK assay to guide cancer chemotherapy (Objective #2.2). Patients will be seen and managed as outpatients or inpatients, depending on a clinical standard of the institution

You may not qualify if…

• Patients with symptomatic/uncontrolled parenchimal brain metastasis and not accessible tumors.
• Patients with meningeal metastasis.
• Patients for whom chemotherapy clinically is not indicated.
• Pregnancy. During the course of the study, all patients of childbearing potential should be instructed to contact the treating physician if they suspect they might have conceived a child; for females, a missing or late menstrual period should be reported to the treating physician. If pregnancy is confirmed by a pregnancy test, the patient must not receive study medication and must not be enrolled into the study or, if already enrolled, must be withdrawn from the study. If a male patient is suspected of having fathered a child while on the study drugs, the pregnant female partner must be notified and counseled regarding the risk to the fetus. Pregnancy during the course of this study will be reported to the Principal Investigator as a serious adverse event. Women of child bearing potential are defined to include any female who has experienced menarche and has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal (defined as amenorrhea for more than 12 consecutive months); these includes also females using oral, implanted, or injectable contraceptive hormones, mechanical devices, or barrier methods to prevent pregnancy.

Where it is running

• Southeastern Gynecologic Oncology — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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