Status:
WITHDRAWN
Azacitidine With Carboplatin and Paclitaxel for Newly Diagnosed Ovarian Cancer
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Celgene Corporation
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This is a clinical trial for women with newly diagnosed ovarian cancer. The purpose of this study is to determine if the addition of a drug called azacitidine (Vidaza®)when added to carboplatin and pa...
Detailed Description
Ovarian cancer is a highly chemosensitive tumor with good responses to first line chemotherapy. The problem is the high rate of relapse, especially in advanced disease Relapses are likely due to the ...
Eligibility Criteria
Inclusion
- Stage III or IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- Appropriately signed and documented informed consent form, with documentation of the informed consent process
- Age more than 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Life expectancy greater than 12 months
- Adequate baseline bone marrow function: absolute neutrophils count greater than 1500 cells/microliter, platelet count greater than 100,000 cells per microliter
- Adequate liver function: bilirubin than 1.5 times the upper limit of normal. Higher levels of Bilirubin are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase (AST)) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase (ALT)) levels less than or equal 2 x Upper Limit of Normal (ULN).
- Adequate renal function: Serum creatinine levels less than or equal to 1.5 times ULN
- Patients must have ascites and be considered not candidates for upfront surgery because of disease bulk (not because of overall health).
- Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
- Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine.
Exclusion
- Ongoing serious infection
- Neuropathy greater than grade 2 at baseline
- Major surgery within 2 weeks prior to enrollment
- Concurrent investigational treatment, antineoplastic treatment, hormonal treatment, or radiation therapy
- Prior bone marrow transplant
- prior radiation to the pelvis
- radiation therapy for malignancy within the past 5 years
- Other malignancy within the past 5 years except non-melanoma skin cancer.
- Known or suspected hypersensitivity to azacitidine or mannitol
- Pregnant or breast feeding
- Patients with advanced malignant hepatic tumors
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00842582
Start Date
February 1 2009
End Date
March 1 2011
Last Update
November 2 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
2
Central Dupage Hospital
Winfield, Illinois, United States, 60190