DOXIL for Consolidation Therapy in Ovarian Cancer.

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective for this study is to evaluate the development, frequency and severity of hand foot syndrome (HFS) in ovarian cancer subjects treated with Doxil®, as consolidation therapy, on an every two week schedule.

The secondary objective for this study is to assess one-year progression free survival rate (PFS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southeastern Gynecologic Oncology
• Collaborator: Ortho Biotech, Inc.
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

1. Subjects must have a initial histopathologic diagnosis of epithelial ovarian cancer, cancer of the fallopian tube or primary peritoneal carcinoma

2. Subjects must have completed front-line platinum based chemotherapy with or without a taxane and be clinically NED (CA 125 <35, negative CT scan, normal physical exam).

3. Subjects must not have had other chemotherapy, radiation, hormonal, or biotherapy within four weeks of initiating Doxil therapy.

4. Doxil treatment must begin within 6 weeks following last cycle of initial chemotherapy.

5. Subjects may have a second look laparoscopy, however, there must be no gross disease present (microscopic disease or pathologically negative).

6. Subjects must have adequate renal function: creatinine < 2.5 mg/dL (< 200 mmol/L).

7. Subjects must have adequate liver functions: total bilirubinnormal (ULN), transaminases (AST/ALT)

8. Subjects must have adequate bone marrow function: Platelets >100,000 cells/mm3, Hemoglobin > 9.0g/dL and ANC > 1,500 cells/mm3.

9. Subjects must be age 18 or greater.

10. Subjects must have signed approved informed consent.

11. Subjects must have a Zubrod Performance Status of 0 or 1. (Appendix A)

12. With the exception of non-melanoma skin cancer, subjects with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years, or whose previous cancer treatment contraindicates this protocol therapy are excluded.

13. Subjects must have no other major systemic medical illness expected to affect survival.

14. Subjects with a life expectancy > 12 weeks.

15. Subjects must have a MUGA scan or 2-d echocardiogram indicating an ejection fraction (LVEF) of > than 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for final monitoring.

Exclusion Criteria:

1. Prior therapy with Doxil, anthracyclines, or anthracendedione. History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil®

2. Prior radiation therapy to more than one-third of the hematopoietic sites.

3. Myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities. See Appendix B (New York State Heart Association Classification).

4. Uncontrolled systemic infection or history of any other unstable serious condition or illness.