Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer

NCT00002819 | Terminated Phase 3

• 5 other identifiers: CDR0000064983GOG-164CLB-9791E-G0164SWOG-G0164
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 64

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known whether chemotherapy alone is more effective than chemotherapy plus peripheral stem cell transplantation for ovarian epithelial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with that of carboplatin, mitoxantrone, and cyclophosphamide followed by peripheral stem cell transplantation in treating patients who have persistent stage III or stage IV ovarian epithelial cancer.

Conditions

Ovarian Cancer

Keywords

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

Interventions

carboplatin DRUG

cyclophosphamide DRUG

mitoxantrone hydrochloride DRUG

paclitaxel DRUG

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator
• SWOG Cancer Research Network: collaborator
• Cancer and Leukemia Group B: collaborator

Study Sites (64)

Veterans Affairs Medical Center - Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94115-0128, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

Veterans Affairs Medical Center - Chicago (Lakeside)

Chicago, Illinois, 60611, United States

Location

University of Illinois at Chicago Health Sciences Center

Chicago, Illinois, 60612, United States

Location

Veterans Affairs Medical Center - Chicago (Westside Hospital)

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Veterans Affairs Medical Center - Togus

Togus, Maine, 04330, United States

Location

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Veterans Affairs Medical Center - Columbia (Truman Memorial)

Columbia, Missouri, 65201, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, 14215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Presbyterian Hospital - Cornell Campus

New York, New York, 10021, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13210, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Veterans Affairs Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102-1192, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Veterans Affairs Medical Center - Memphis

Memphis, Tennessee, 38104, United States

Location

University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, 38163, United States

Location

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, 37212, United States

Location

Vanderbilt Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

Veterans Affairs Medical Center - White River Junction

White River Junction, Vermont, 05009, United States

Location

Veterans Affairs Medical Center - Richmond

Richmond, Virginia, 23249, United States

Location

MBCCOP - Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

CCOP - Marshfield Medical Research and Education Foundation

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Brenner Tumor

Interventions

Carboplatin; Cyclophosphamide; Mitoxantrone; Paclitaxel; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Quinones; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• William P. McGuire, MD

  Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

  STUDY CHAIR

• Kenneth B. Miller, MD

  Tufts Medical Center Cancer Center

  STUDY CHAIR

• Patrick J. Stiff, MD

  Loyola University

  STUDY CHAIR

• Stephen L. Graziano, MD

  State University of New York - Upstate Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 26, 2004
• Study Start: November 1, 1996
• Primary Completion: February 1, 2000
• Last Updated: April 11, 2013

Record last verified: 2007-05

Locations

US (64)