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A Phase II/III Trial of Chemotherapy Alone Versus Chemotherapy Plus SCH 58500 in Newly Diagnosed Stage III Ovarian and Primary Peritoneal Cancer Patients With Greater Than or Equal to 0.5 cm and Less Than or Equal to 2 cm Residual Disease Following Surgery


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II/III Trial of Chemotherapy Alone Versus Chemotherapy Plus SCH 58500 in Newly Diagnosed Stage III Ovarian and Primary Peritoneal Cancer Patients With Greater Than or Equal to 0.5 cm and Less Than or Equal to 2 cm Residual Disease Following Surgery


OBJECTIVES: I. Assess the effect of paclitaxel and carboplatin with or without SCH 58500 on
progression free survival, overall survival, safety, response, and CA-125 levels in patients
with newly diagnosed stage III ovarian epithelial or primary peritoneal cancer.

OUTLINE: This is a randomized, open label, multicenter study. Patients receive treatment of
IV paclitaxel and IV carboplatin. Patients are randomized to one of two treatment groups:
Arm I: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin,
on day 1. Courses are repeated every 21 days. Arm II: Patients receive IV paclitaxel over 3
hours, immediately followed by IV carboplatin, on day 1. Patients receive intraperitoneal
SCH 58500 on days 1-5. Courses are repeated every 21 days. Patients are followed every 6
weeks for 36 months, then every 3 months for 2 years, and then every 6 months until disease
progression.

PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage III ovarian epithelial or primary
peritoneal cancer with residual disease no greater than 2 cm following cytoreductive
surgery The following cell types are eligible: Serous adenocarcinoma, mucinous
adenocarcinoma, clear cell adenocarcinoma, transitional cell, adenocarcinoma NOS,
endometrioid adenocarcinoma, mixed epithelial carcinoma, or peritoneal serous papillary
carcinoma Total abdominal hysterectomy with salpingo-oophorectomy or supracervical
hysterectomy, omentectomy, tumor reduction, lymph node assessment, and debulking if nodes
2 cm or greater No endometrial malignancy treated with supracervical hysterectomy No
cytologically positive pleural effusion No tumors of borderline histology No cancer of the
fallopian tubes

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit
of normal (ULN) SGOT no greater than 2 times ULN Alkaline phosphatase no greater than 2
times ULN Renal: Creatinine no greater than 2 mg/dL Glomerular filtration rate no less
than 30 Other: HIV negative Not pregnant or nursing Fertile patients must use effective
contraception No other serious medical condition No other prior malignancies except
carcinoma in situ of the cervix, nonmelanomatous skin cancer, Dukes A colorectal cancer
from which patient has been disease free for past 5 years, or stage I or II breast cancer
from which patient has been disease free for past 10 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Concurrent cytokine therapy allowed
Chemotherapy: No more than 1 prior chemotherapy course for ovarian or peritoneal cancer At
least 10 years since prior adjuvant chemotherapy for breast cancer Endocrine therapy: At
least 3 months since prior systemic corticosteroid or other immunosuppressive therapy
Concurrent female hormonal replacement allowed Radiotherapy: No prior radiotherapy for
ovarian or peritoneal cancer No prior radiotherapy to abdomen Surgery: Prior surgery
allowed Other: No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jo Ann Horowitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Schering-Plough

Authority:

United States: Federal Government

Study ID:

CDR0000067047

NCT ID:

NCT00003880

Start Date:

February 1999

Completion Date:

Related Keywords:

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

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
Stanford University Medical CenterStanford, California  94305-5408
University of Colorado Cancer CenterDenver, Colorado  80262
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 Minnesota Cancer CenterMinneapolis, Minnesota  55455
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
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Abington Memorial HospitalAbington, Pennsylvania  19001
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
New York Medical CollegeValhalla, New York  10595
University of Texas Medical BranchGalveston, Texas  77555-1329
Cedars-Sinai Medical CenterLos Angeles, California  90048
Lombardi Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
St. Barnabas Medical CenterLivingston, New Jersey  07039
Texas Oncology, P.A.Dallas, Texas  75246
University of California Davis Cancer CenterSacramento, California  95817
Wesley Medical CenterWichita, Kansas  67214
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Greenville Hospital SystemGreenville, South Carolina  29605
Providence Hospital Cancer CenterSouthfield, Michigan  48075
Walt Disney Memorial Cancer InstituteOrlando, Florida  32803
University of New Mexico School of MedicineAlbuquerque, New Mexico  87131
University of Florida Health Science Center - JacksonvilleJacksonville, Florida  32209
Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Woman's HospitalBaton Rouge, Louisiana  70815
Arizona Clinical Research CenterTucson, Arizona  85712
Loma Linda University Cancer InstituteLoma Linda, California  92354
Rocky Mountain Gynecologic OncologyEnglewood, Colorado  80110
Southeastern Gynecologic OncologyDecatur, Georgia  30033
Ochsner Cancer InstituteNew Orleans, Louisiana  70121
Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
G. Rainey Williams PavilionOklahoma City, Oklahoma  73190
Mercy Cancer InstitutePittsburgh, Pennsylvania  15219
Pacific Gynecology SpecialistsSeattle, Washington  98104