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A RANDOMIZED, CONTROLLED TRIAL OF SALVAGE THERAPY WITH PACLITAXEL AND CARBOPLATIN VERSU SALVAGE THERAPY WITH STEM CELL SUPPORTED HIGH-DOSE CARBOPLATIN, MITOXANTRONE AND CYCLOPHOSPHAMIDE IN PATIENTS WITH PERSISTENT LOW VOLUME OVARIAN CANCER AND RESPONSE TO PRIMARY THERAPY


Phase 3
N/A
65 Years
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

A RANDOMIZED, CONTROLLED TRIAL OF SALVAGE THERAPY WITH PACLITAXEL AND CARBOPLATIN VERSU SALVAGE THERAPY WITH STEM CELL SUPPORTED HIGH-DOSE CARBOPLATIN, MITOXANTRONE AND CYCLOPHOSPHAMIDE IN PATIENTS WITH PERSISTENT LOW VOLUME OVARIAN CANCER AND RESPONSE TO PRIMARY THERAPY


OBJECTIVES: I. Compare progression-free and overall survival of patients with
drug-sensitive, low-volume ovarian cancer that is persistent following standard therapy
treated with salvage therapy comprising standard-dose paclitaxel and carboplatin vs
high-dose carboplatin, mitoxantrone, and cyclophosphamide followed by bone marrow
reconstitution. II. Compare the toxic effects of these two salvage regimens. III. Compare
selected health-related aspects of quality of life in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
center and disease state at reassessment laparotomy. Patients are randomized to one of two
treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and carboplatin
IV continuously on days 1-5 every 3 weeks for a total of 6 courses. Arm II: Patients receive
cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4,
and carboplatin IV continuously on days -8 through -4, followed by rescue with autologous
bone marrow or peripheral blood stem cells on day 0. Quality of life is assessed at
baseline, at 3 and 9 weeks after starting treatment, and every 3 months for an additional 5
assessments regardless of disease progression.

PROJECTED ACCRUAL: A total of 275 patients will be accrued over approximately 60 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial
carcinoma including the following cellular diagnoses: Serous adenocarcinoma Mucinous
adenocarcinoma Endometrioid adenocarcinoma Clear cell adenocarcinoma Undifferentiated
carcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor
Stage III (optimal or suboptimal) must be surgically reassessed OR Stage III (suboptimal)
or stage IV clinically reassessed after induction chemotherapy For stage III surgical
reassessment: No more than 12 weeks between end of chemotherapy and reassessment surgery
AND No more than 6 weeks between reassessment surgery and randomization Patients treated
on protocol GOG-158 are eligible At least a partial response to chemotherapy as defined
as: Microscopic disease documented at reassessment surgery for patients optimally debulked
(disease no greater than 1 cm) after primary surgery Suboptimally debulked disease
(greater than 1 cm) after primary surgery and 1 of the following: Negative reassessment
laparotomy Only microscopic disease at reassessment surgery Gross residual disease no
greater than 1 cm at reassessment surgery prior to debulking Clinical complete response to
induction chemotherapy including: - suboptimal disease Stage III or IV AND - either an
abnormal CT or elevated CA-125 prior to induction chemotherapy and both are within normal
limits following induction chemotherapy

PATIENT CHARACTERISTICS: Age: Under 66 Performance status: GOG 0 or 1 Hematopoietic:
Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times normal Renal: Creatinine
clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least
45% by MUGA No congestive heart failure Pulmonary: FEV1 and FVC at least 60% Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No prior malignancy in the past 5 years except adequately treated
nonmelanomatous skin cancer, carcinoma in situ of the cervix, or any other cancer whose
prior treatment does not contraindicate this study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 4 and no more than 6 prior platinum-based combination
chemotherapy courses (i.e., cisplatin or carboplatin) required Endocrine therapy: Not
specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior
anthracyclines

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

William P. McGuire, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

Authority:

United States: Federal Government

Study ID:

CDR0000064983

NCT ID:

NCT00002819

Start Date:

November 1996

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage III ovarian epithelial 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
  • Brenner tumor
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
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
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
CCOP - Merit Care HospitalFargo, North Dakota  58122
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212