DOXIL for Consolidation Therapy in Ovarian Cancer.

NCT00248248 | Completed Phase 2

• 1 other identifier: SEGO_DOXIL_CONS2005
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Ovarian Neoplasm

Keywords

Consolidation; Ovarian cancer; DOXIL; Hand-foot syndrome

Outcome Measures

Primary Outcomes (1)

• Development, frequency, and severity of hand-foot syndrome with every two week therapy

  5 years

Secondary Outcomes (1)

• One-year progression free survival

  2 years

Interventions

liposomal doxorubicin DRUG

Doxil at 50mg/m2 infused over one hour every 3 or 4 weeks for 3-6 cycles

Eligibility Criteria

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

You may qualify if:

• Subjects must have a initial histopathologic diagnosis of epithelial ovarian cancer, cancer of the fallopian tube or primary peritoneal carcinoma
• 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).
• Subjects must not have had other chemotherapy, radiation, hormonal, or biotherapy within four weeks of initiating Doxil therapy.
• Doxil treatment must begin within 6 weeks following last cycle of initial chemotherapy.
• Subjects may have a second look laparoscopy, however, there must be no gross disease present (microscopic disease or pathologically negative).
• Subjects must have adequate renal function: creatinine \< 2.5 mg/dL (\< 200 mmol/L).
• Subjects must have adequate liver functions: total bilirubin \</=1.5 x upper limit of normal (ULN), transaminases (AST/ALT) \</=2.5 x ULN
• Subjects must have adequate bone marrow function: Platelets \>100,000 cells/mm3, Hemoglobin \> 9.0g/dL and ANC \> 1,500 cells/mm3.
• Subjects must be age 18 or greater.
• Subjects must have signed approved informed consent.
• Subjects must have a Zubrod Performance Status of 0 or 1. (Appendix A)
• 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.
• Subjects must have no other major systemic medical illness expected to affect survival.
• Subjects with a life expectancy \> 12 weeks.
• 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.

You may not qualify if:

• Prior therapy with Doxil, anthracyclines, or anthracendedione. History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil®
• Prior radiation therapy to more than one-third of the hematopoietic sites.
• 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).
• Uncontrolled systemic infection or history of any other unstable serious condition or illness.

Sponsors & Collaborators

• Southeastern Gynecologic Oncology: lead
• Ortho Biotech, Inc.: collaborator

Study Sites (1)

Southeastern Gynecologic Oncology

Atlanta, Georgia, 30342, United States

Location

Related Publications (2)

• Gordon AN, Tonda M, Sun S, Rackoff W; Doxil Study 30-49 Investigators. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol. 2004 Oct;95(1):1-8. doi: 10.1016/j.ygyno.2004.07.011.

  PMID: 15385103 BACKGROUND

• Rose PG, Maxson JH, Fusco N, Mossbruger K, Rodriguez M. Liposomal doxorubicin in ovarian, peritoneal, and tubal carcinoma: a retrospective comparative study of single-agent dosages. Gynecol Oncol. 2001 Aug;82(2):323-8. doi: 10.1006/gyno.2001.6272.

  PMID: 11531287 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Hand-Foot Syndrome

Interventions

liposomal doxorubicin

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; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Jeffrey F Hines, MD, FACOG

  Southeastern Gynecologic Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2005
• First Posted: November 3, 2005
• Study Start: October 1, 2005
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

US (1)