DOXIL for Consolidation Therapy in Ovarian Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00248248
Recruitment Status : Completed
First Posted : November 3, 2005
Last Update Posted : October 12, 2011
Ortho Biotech, Inc.
Information provided by (Responsible Party):
Southeastern Gynecologic Oncology

Brief 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).

Condition or disease Intervention/treatment Phase
Ovarian Neoplasm Drug: liposomal doxorubicin Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Non-randomized Study of DOXIL Consolidation Treatment for Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneal Carcinoma.
Study Start Date : October 2005
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Intervention Details:
    Drug: liposomal doxorubicin
    Doxil at 50mg/m2 infused over one hour every 3 or 4 weeks for 3-6 cycles

Primary Outcome Measures :
  1. Development, frequency, and severity of hand-foot syndrome with every two week therapy [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. One-year progression free survival [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 bilirubin </=1.5 x upper limit of normal (ULN), transaminases (AST/ALT) </=2.5 x ULN
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00248248

United States, Georgia
Southeastern Gynecologic Oncology
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Southeastern Gynecologic Oncology
Ortho Biotech, Inc.
Principal Investigator: Jeffrey F Hines, MD, FACOG Southeastern Gynecologic Oncology

Additional Information:
Responsible Party: Southeastern Gynecologic Oncology Identifier: NCT00248248     History of Changes
Other Study ID Numbers: SEGO_DOXIL_CONS2005
First Posted: November 3, 2005    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by Southeastern Gynecologic Oncology:
Ovarian cancer
Hand-foot syndrome

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action