Azacitidine With Carboplatin and Paclitaxel for Newly Diagnosed Ovarian Cancer

Withdrawn before enrolling · Phase 1

Conditions studied: Ovarian Cancer

In brief

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 paclitaxel will change the genetic material of the tumor so that the chemotherapy drugs work better. The study will also determine what the maximum tolerated dose of azacitidine that may be safely used in combination with carboplatin and paclitaxel.

Key facts

Study ID

NCT00842582

Run by

Loyola University

People needed

0

Starts

2009-02-01

Expected to finish

2011-03-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
• Central Dupage Hospital — Winfield, Illinois, United States

Full record on ClinicalTrials.gov

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