NCT00022620

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have refractory or recurrent endometrial cancer.

Trial Health

90
On Track

Trial Health Score

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

Geographic Reach
6 countries

8 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

1.3 years

First QC Date

August 10, 2001

Last Update Submit

September 20, 2012

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinomaendometrial papillary serous carcinoma

Interventions

paclitaxelDRUG

Eligibility Criteria

AgeUp to 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma) * Progressive or recurrent * Bidimensionally measurable disease * Platinum refractory disease, defined by one of the following: * Progression during platinum-based chemotherapy * Stable disease for at least 4 courses of platinum-based chemotherapy * Recurrence within 4 months of platinum-based chemotherapy * No brain involvement or leptomeningeal disease PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 50 umol/L Renal: * BUN no greater than 8.0 mmol/L * Creatinine no greater than 120 umol/L * Creatinine clearance at least 60 mL/min Other: * Not pregnant * Fertile patients must use effective contraception * HIV negative * No other prior or concurrent malignancy except basal cell carcinoma of the skin * No active bacterial infection (e.g., urinary tract infection) * No uncontrolled or potentially active site of infection (e.g., fistula or abscess) * No psychological, familial, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * At least 1 prior platinum containing regimen * At least 50 mg/m2 per course for a maximum of 28 days for cisplatin * At least 5 times AUC for a maximum of 4 weeks per course for carboplatin * Prior non-taxane-containing chemotherapy allowed Endocrine therapy: * At least 4 weeks since prior hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy * At least 3 months since prior radiotherapy to target lesion * Concurrent radiotherapy allowed for bone pain provided evaluable lesions are outside of irradiation field) Surgery: * Prior surgical management of lymph nodes allowed

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

Sponsors & Collaborators

Study Sites (8)

Allgemeines Krankenhaus der Stadt Wien

Vienna, A-1090, Austria

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Ospedale Mauriziano Umberto I

Torino, 10128, Italy

Location

Ospedale Civile

Voghera (PV), 27058, Italy

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3049, Portugal

Location

Hospital Universitasrio San Carlos

Madrid, 28040, Spain

Location

Queen Elizabeth Hospital

Gateshead, England, NE9 6SX, United Kingdom

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Gerald Gitsch, MD

    Allgemeines Krankenhaus - Universitatskliniken

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

June 1, 2001

Primary Completion

October 1, 2002

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

AU(1)BE(2)PT(1)IT(2)GB(1)ES(1)