NCT00005051

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Last Updated

November 9, 2012

Status Verified

December 1, 2003

Enrollment Period

3.6 years

First QC Date

April 6, 2000

Last Update Submit

November 8, 2012

Conditions

Ovarian Cancer

Keywords

stage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancer

Interventions

carboplatinDRUG
cisplatinDRUG
paclitaxelDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery * Stage IC, II, III, or IV PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * SGOT no greater than 3 times upper limit of normal * Bilirubin no greater than 2.0 mg/dL * No clinically significant hepatic disorder Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min * No clinically significant renal disorder Cardiovascular: * No clinically significant cardiovascular condition Other: * Normal GI function allowing reliable administration of oral medication * No active infection requiring systemic medical therapy within past week * No other clinically significant medical condition (e.g., endocrine/metabolic or autoimmune disorder) * No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No dementia or altered mental status that would preclude consent * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for ovarian epithelial carcinoma Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for ovarian epithelial carcinoma Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (10)

New York Hospital Medical Center of Queens

Fresh Meadows, New York, 11365, United States

Location

Saint Vincent Catholic Medical Center of New York

New York, New York, 10011, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

St. Luke's-Roosevelt Hospital Center - Roosevelt Division

New York, New York, 10019, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-3236, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

CarboplatinCisplatinPaclitaxelTopotecan

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Howard S. Hochster, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2000

First Posted

January 27, 2003

Study Start

August 1, 1999

Primary Completion

March 1, 2003

Last Updated

November 9, 2012

Record last verified: 2003-12

Locations

US(10)