Azacitidine With Carboplatin and Paclitaxel for Newly Diagnosed Ovarian Cancer

NCT00842582 | Withdrawn Phase 1

• 1 other identifier: 200777
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Ovarian Cancer

Keywords

Ovarian cancer; chemotherapy; azacitidine

Outcome Measures

Primary Outcomes (1)

• 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.

  15 days

Secondary Outcomes (1)

• 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.

  5 years

Study Arms (1)

Single group assignment

EXPERIMENTAL

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

Drug: Azacitidine

Interventions

Azacitidine DRUG

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

Single group assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Loyola University: lead
• Celgene Corporation: collaborator

Study Sites (2)

Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center

Maywood, Illinois, 60153, United States

Location

Central Dupage Hospital

Winfield, Illinois, 60190, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Laura Horvath, MD

  Loyola University Cardinal Bernadin Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)