Azacitidine and Valproic Acid Plus Carboplatin in Patients With Ovarian Cancer

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to find out if giving azacitidine with valproic acid plus carboplatin can help control advanced cancer. The safety of this treatment will be studied as well. Researchers will also collect some extra blood samples for molecular marker studies (studies that may help researchers predict how participants respond to the combined therapy).

There were to be two phases of this study: a Phase 1 portion to find acceptable doses of the study drug combination, and a Phase 2 portion to study the response rates to the treatment schedule. The study did not proceed to the Phase 2 portion.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Celgene Corporation
• Treatments: Azacitidine; Carboplatin; Valproic Acid

Criteria

Inclusion Criteria:

1. Patient has histologically or cytologically confirmed diagnosis of advanced solid tumor (that has progressed following standard therapy or for whom, in the opinion of the investigator, no standard effective therapy is available) during the phase I study. Only patients who have platinum resistant epithelial carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma are enrolled onto the phase 2 study, if progresses to phase 2. According to standard Gynecologic Oncology Group (GOG) criteria platinum resistant is defined to have had a disease-free interval of shorter than 6 months following platinum treatment.

2. Patient has measurable or evaluable disease by radiological imaging techniques with documented progression within 1 month before study entry or disease that has not responded to treatment. (Pleural effusions, ascites, osseous metastasis, elevation of tumor marker and lesions located in previously irradiated areas are not considered measurable).

3. Patient is willing to comply with study procedures to have blood collections for correlative studies.

4. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

5. Patient must be informed of the investigational nature of this study and must sign and give written Internal Review Board (IRB) approved informed consent in accordance with institutional guidelines.

6. If patient is of child-bearing potential, she or he has agreed to practice an effective method of birth control during the study and up to 3 months after the last treatment.

7. Patient has adequate liver and renal function: serum albumin =/>3.0 g/dL; serum bilirubin =/<2.0 mg/dL; alanine aminotransferase (ALT) =/<3* upper limit of normal (uln); and serum creatinine =/< 2.0 mg/dL or a calculated creatinine clearance of at least 40 ml/min.

8. Patient has adequate bone marrow reserve. Absolute neutrophil count (ANC) =/>1,500/ul, Platelet count =/>100,000/ul, and Hemoglobin =/>9.0g/dL.

Exclusion Criteria:

1. Any concurrent chemotherapy.

2. Underlying medical condition that might be aggravated by treatment or that cannot be controlled, such as active uncontrolled serious infection and cardiac dysfunction.

3. Medical and psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.

4. Known hypersensitivity to azacitidine, valproic acid, carboplatin or their analogs.

5. Failure to recover from any prior surgery within 4 weeks of study entry.

6. Pregnant or lactating.

7. Any treatment specific for tumor control within 3 weeks of dosing with study drugs (within 2 weeks if given weekly or within 6 weeks for nitrosoureas or mitomycin C) or failure to recover from the toxic effect of any of these therapies prior to study entry. Any investigational drug within 30 days of first day of dosing.

8. Any signs of intestinal obstruction interfering with nutrition or oral intake.

9. History of central nervous system (CNS) metastasis unless the patient has had surgery or radiation, and does not require oral or intravenous corticosteroids or anticonvulsants.

10. Advanced malignant hepatic tumors that are defined as the total hepatic metastases more than 25% of hepatic parenchyma.

11. History of high dose chemotherapy for ovarian cancer in phase 2 of the study, if Phase 2 of study needed. High dose chemotherapy is defined as the intensity and/or the density of a chemotherapeutic agent that are beyond standard of care for ovarian cancer treatment.

12. History of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease free for at least two years in phase 2 study, if Phase 2 of study needed.