NCT00003334

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 combining doxorubicin and paclitaxel in treating patients who have recurrent or refractory endometrial cancer, fallopian tube cancer, or sarcoma of the female reproductive tract.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

5 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

March 1, 1997

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

February 9, 2004

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

4.8 years

First QC Date

November 1, 1999

Last Update Submit

March 10, 2016

Conditions

Endometrial CancerFallopian Tube CancerOvarian CancerSarcoma

Keywords

stage IV endometrial carcinomarecurrent endometrial carcinomafallopian tube cancerstage IV uterine sarcomarecurrent uterine sarcomauterine carcinosarcomauterine leiomyosarcomaendometrial stromal sarcomaovarian sarcomaovarian carcinosarcoma

Interventions

paclitaxelDRUG
pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility Criteria

AgeUp to 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory carcinoma of the endometrium or fallopian tubes or sarcomas of gynecologic origin including mixed mesodermal sarcomas Documented recurrence or persistence of disease after appropriate surgical and/or radiation therapy Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count at least 50,000/mm3 Granulocyte count at least 1,000/mm3 Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 3 times ULN Renal: Creatinine less than 2.5 mg/dL Cardiovascular: MUGA at least lower limit of normal Normal ejection fraction and/or stable cardiac status Other: No medical or social factors that would interfere with compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious concurrent illness requiring immediate therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 months since prior combined modality or adjuvant chemotherapy Prior doxorubicin allowed if cumulative dose is recorded Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: At least 30 days since prior noncytotoxic experimental antiemetic or antifungal investigational drugs

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

Sponsors & Collaborators

Study Sites (5)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, 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

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Related Publications (1)

  • Hornreich G, Muggia FM, Wadler S, et al.: Phase II combination doxil-paclitaxel (PacliDox) in uterine carcinomas and sarcomas - an active regimen: a New York Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists 2003 Annual Meeting on Women's Cancer, January 31 - February 2, 2003, New Orleans, Louisiana. A-606, 2003.

    RESULT

MeSH Terms

Conditions

Endometrial NeoplasmsFallopian Tube NeoplasmsOvarian NeoplasmsSarcomaSarcoma, Endometrial Stromal

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms, Complex and MixedEndometrial Stromal Tumors

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Franco M. Muggia, 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

November 1, 1999

First Posted

February 9, 2004

Study Start

March 1, 1997

Primary Completion

December 1, 2001

Last Updated

March 11, 2016

Record last verified: 2016-03

Locations

US(5)