Status:
COMPLETED
Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas
Lead Sponsor:
Pierian Biosciences
Conditions:
Adenocarcinoma
Ovarian Neoplasms
Eligibility:
FEMALE
Phase:
PHASE2
PHASE3
Brief Summary
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 t...
Detailed Description
1. 0 Background and Rationale: Despite the use of aggressive treatment protocols, less than 10% of cancer patients with an advanced disease respond to the therapy. There is a variety of different canc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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the patient must not receive study medication and must not be enrolled into the study or, if already enrolled, must be withdrawn from the study.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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00443196
Start Date
March 1 2006
End Date
September 1 2010
Last Update
March 12 2018
Active Locations (1)
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1
Southeastern Gynecologic Oncology
Atlanta, Georgia, United States, 30342