DOXIL for Consolidation Therapy in Ovarian Cancer.

This study has been completed.
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
Southeastern Gynecologic Oncology
ClinicalTrials.gov Identifier:
NCT00248248
First received: November 1, 2005
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Ovarian Neoplasm
Drug: liposomal doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Southeastern Gynecologic Oncology:

Primary Outcome Measures:
  • Development, frequency, and severity of hand-foot syndrome with every two week therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • One-year progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: October 2005
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: liposomal doxorubicin
    Doxil at 50mg/m2 infused over one hour every 3 or 4 weeks for 3-6 cycles
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248248

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

Additional Information:
Publications:
Responsible Party: Southeastern Gynecologic Oncology
ClinicalTrials.gov Identifier: NCT00248248     History of Changes
Other Study ID Numbers: SEGO_DOXIL_CONS2005
Study First Received: November 1, 2005
Last Updated: October 7, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014