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A Phase I Study of Liposomal Doxorubicin (Doxil) and Prolonged Etoposide As Second Line Therapy in Ovarian, Tubal and Peritoneal Carcinoma


Phase 1
N/A
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase I Study of Liposomal Doxorubicin (Doxil) and Prolonged Etoposide As Second Line Therapy in Ovarian, Tubal and Peritoneal Carcinoma


OBJECTIVES: I. Determine the optimal dose of doxorubicin HCl liposomal and prolonged oral
etoposide in patients with recurrent or persistent ovarian, tubal, and peritoneal carcinoma.
II. Determine the nature and degree of toxicity of this therapy in these patients. III.
Evaluate the response rate of patients with measurable disease.

OUTLINE: This is a dose escalation, multicenter study of etoposide and doxorubicin HCl
liposome. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by
oral etoposide for 8-14 days beginning on day 2. For patients who achieve partial or
complete response, treatment repeats every 4 weeks for 1 year in the absence of disease
progression or unacceptable toxicity. For patients with stable disease, treatment repeats
every 4 weeks for 6 months. In the absence of dose limiting toxicity (DLT) in the first 3
patients treated, subsequent cohorts of 3-6 patients each receive doses of etoposide for
more prolonged periods. After 14 days of oral etoposide, the dose of doxorubicin HCl
liposome is escalated. The maximum tolerated dose is defined as the dose preceding that at
which 2 of 6 patients experience DLT. Patients are followed every 3 months for 1 year, then
until death.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven recurrent or persistent ovarian, tubal, or
peritoneal carcinoma of the following cell types: Serous adenocarcinoma Mucinous
adenocarcinoma Clear cell adenocarcinoma Transitional cell Endometrioid adenocarcinoma
Undifferentiated carcinoma Mixed epithelial carcinoma Malignant Brenner tumor
Adenocarcinoma not otherwise specified Must not be eligible for any other higher priority
phase II or phase III GOG protocol

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal
SGOT/SGPT/GGT no greater than 2.5 times normal Alkaline phosphatase no greater than 2.5
times normal No acute hepatitis Renal: Creatinine no greater than 2.0 mg/dL Creatinine
clearance greater than 50 mL/min Cardiovascular: LVEF within normal range as determined by
MUGA No congestive heart failure or unstable angina No myocardial infarction within the
past 6 months Prior abnormal cardiac conduction (e.g., bundle branch block, heart block)
allowed if stable for at least 6 months Other: No significant infection No septicemia Body
surface area at least 1 m2 Adequate intestinal function (i.e., does not require IV
hydration or nutritional support) No severe gastrointestinal bleeding No other invasive
malignancies within the past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
and recovered Chemotherapy: Must have received at least 1 prior cisplatin-paclitaxel based
regimen At least 3 weeks since prior chemotherapy and recovered No prior anthracycline
therapy Endocrine therapy: At least 3 weeks since prior endocrine therapy and recovered
Radiotherapy: No prior radiotherapy to more than 10% of bone marrow Surgery: At least 3
weeks since prior surgery and recovered

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter G. Rose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000066375

NCT ID:

NCT00003380

Start Date:

May 1998

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • ovarian undifferentiated adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Brenner tumor
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
University of Colorado Cancer Center Denver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
Women's Cancer Center Palo Alto, California  94304
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
Brookview Research, Inc. Winston-Salem, North Carolina  27103
Pennsylvania Hospital Philadelphia, Pennsylvania  19107
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Evanston Evanston, Illinois  60201
North Shore University Hospital Manhasset, New York  11030
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Medicine Branch Bethesda, Maryland  20892
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Radiation Oncology Branch Bethesda, Maryland  20892