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A Phase I Feasibility Trial of Carboplatin and Topotecan Followed by Carboplatin and Paclitaxel (Sequential Doublets) in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma


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

Thank you

Trial Information

A Phase I Feasibility Trial of Carboplatin and Topotecan Followed by Carboplatin and Paclitaxel (Sequential Doublets) in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma


OBJECTIVES: I. Determine the feasibility of administering multiple courses of carboplatin
and topotecan without excessive dose modification or course delay in patients with
previously untreated ovarian epithelial or primary peritoneal carcinoma. II. Describe the
response rate and progression-free interval in these patients with this treatment regimen.
III. Determine pharmacokinetic and pharmacodynamic parameters related to the sequence of
carboplatin and topotecan administration in these patients.

OUTLINE: Patients are assigned to one of three treatment regimens. Regimen I: Patients
receive carboplatin IV over 30 minutes on day 1 followed by topotecan IV over 30 minutes on
days 1-3. Treatment continues every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours
followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity. Regimen II: Patients
receive topotecan IV over 30 minutes on days 1-3 followed by carboplatin IV over 30 minutes
on day 3. Treatment continues every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours
followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity. Regimen III:
Patients receive topotecan IV over 30 minutes on days 1-5 followed by carboplatin IV over 30
minutes on day 5. Treatment continues every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours
followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity. Patients are
followed at 1 month and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 15-80 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial or
primary peritoneal carcinoma Prior surgery required within the past 12 weeks Either
optimal (no greater than 1 cm residual disease) or suboptimal residual disease following
initial surgery No ovarian epithelial tumors of low malignant potential (borderline tumor)
The following histologic epithelial cell types are eligible: Serous adenocarcinoma
Mucinous adenocarcinoma Clear cell adenocarcinoma Transitional cell carcinoma
Adenocarcinoma not otherwise specified Endometrioid adenocarcinoma Undifferentiated
carcinoma Mixed epithelial carcinoma Malignant Brenner tumor

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of
normal (ULN) SGOT and alkaline phosphatase no greater than 2.5 times ULN No acute
hepatitis Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable
angina No myocardial infarction within past 6 months Abnormal cardiac conduction (e.g.,
bundle branch block, heart block) allowed if stable for past 6 months Other: No septicemia
or severe infection No severe gastrointestinal bleeding No concurrent or prior invasive
malignancies within past 5 years except nonmelanoma skin cancer No greater than grade 1
neuropathy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
See Disease Characteristics Other: No prior cancer treatment that contraindicates study
protocol

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael A. Bookman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067547

NCT ID:

NCT00005026

Start Date:

February 2000

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • ovarian undifferentiated adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • primary peritoneal cavity cancer
  • Brenner tumor
  • Carcinoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
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
University of Rochester Cancer CenterRochester, New York  14642
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
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
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
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Tacoma General HospitalTacoma, Washington  98405
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Community Hospital of Los GatosLos Gatos, California  95032
Tufts University School of MedicineBoston, Massachusetts  02111
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Tampa Bay Cancer ConsortiumSaint Petersburg, Florida  33701
Radiation Oncology BranchBethesda, Maryland  20892
Ellis Fischel Cancer CenterColumbia, Missouri  65203