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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 CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
Women's Cancer CenterPalo Alto, California  94304
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
Brookview Research, Inc.Winston-Salem, North Carolina  27103
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - EvanstonEvanston, Illinois  60201
North Shore University HospitalManhasset, New York  11030
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Medicine BranchBethesda, Maryland  20892
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Radiation Oncology BranchBethesda, Maryland  20892