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Azacitidine With Carboplatin and Paclitaxel for Newly Diagnosed Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Azacitidine

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian cancer, chemotherapy, azacitidine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center
Central Dupage Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single group assignment

Arm Description

Patients will receive Azacitidine at 20, 40, or 75 milligrams per meter squared subcutaneous once daily for 7 days.

Outcomes

Primary Outcome Measures

The primary goal is to find the lowest dose of azacitidine combined with carboplatin and Paclitaxel, at which toxicity is reasonable, and methylation changes are clinically significant (at which there is a change in gene expression.

Secondary Outcome Measures

Secondary endpoints are disease free survival, overall survival, toxicity, quality of life as measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer symptom (FOSI) index, and basic science correlate.

Full Information

NCT ID

NCT00842582

First Posted

February 11, 2009

Last Updated

November 1, 2016

Sponsor

Loyola University

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00842582

Brief Title

Azacitidine With Carboplatin and Paclitaxel for Newly Diagnosed Ovarian Cancer

Official Title

Neoadjuvant Azacitidine With Carboplatin and Paclitaxel for Suboptimal Newly Diagnosed Ovarian Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Withdrawn

Why Stopped

No enrollment. Unable to recruit due to lack of eligible patients.

Study Start Date

February 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Loyola University

Collaborators

Celgene Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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 presence of chemoresistant cells that escape from first line platinum and taxane based regimens. Therefore, outcomes may be improved by adding treatment to initial standard therapy that makes resistant cells sensitive to chemotherapy. There are multiple targeted pathways that may achieve this goal. One promising path is epigenetics. The reasons for this trial are multifold. First, methylation pathways have been proven in tissue models to be integral to ovarian cancer pathogenesis. Second, cisplatin and azacitidine are synergistic, and therefore would be promising in combination to improve ovarian cancer outcomes by combating cisplatin resistance, which is a major cause of ovarian cancer mortality. It has been proven that azacitidine/decitabine reverses platinum resistance. Third, azacitidine has shown tolerable toxicity and promise in clinical trials to date. Ideally, ovarian cancer outcomes are likely to be improved by the addition of treatment that wipes out chemoresistant cells, thus preventing relapse. This study is a phase I, non-randomized, dose escalation treatment study using azacitidine in combination with intravenous chemotherapy with Paclitaxel and carboplatin. All patients will receive the chemotherapy drugs Carboplatin and Paclitaxel. Patients will then be randomized to receive one of three different doses of Azacitidine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

Ovarian cancer, chemotherapy, azacitidine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single group assignment

Arm Type

Experimental

Arm Description

Patients will receive Azacitidine at 20, 40, or 75 milligrams per meter squared subcutaneous once daily for 7 days.

Intervention Type

Drug

Intervention Name(s)

Azacitidine

Intervention Description

Azacitidine 20 milligrams per meter squared subcutaneous once daily for 7 days.

Intervention Type

Drug

Intervention Name(s)

Azacitidine

Intervention Description

Azacitidine 40 milligrams per meter squared subcutaneous once daily for 7 days.

Intervention Type

Drug

Intervention Name(s)

Azacitidine

Intervention Description

Azacitidine 75 milligrams per meter squared subcutaneous once daily for 7 days.

Primary Outcome Measure Information:

Title

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Horvath, MD

Organizational Affiliation

Loyola University Cardinal Bernadin Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Central Dupage Hospital

City

Winfield

State/Province

Illinois

ZIP/Postal Code

60190

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Azacitidine With Carboplatin and Paclitaxel for Newly Diagnosed Ovarian Cancer

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