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Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
paclitaxel
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring recurrent endometrial carcinoma, endometrial papillary serous carcinoma

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Allgemeines Krankenhaus der Stadt Wien
  • Universitair Ziekenhuis Antwerpen
  • U.Z. Gasthuisberg
  • Ospedale Mauriziano Umberto I
  • Ospedale Civile
  • Hospitais da Universidade de Coimbra (HUC)
  • Hospital Universitasrio San Carlos
  • Queen Elizabeth Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00022620
Brief Title
Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
Official Title
Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine the therapeutic activity of paclitaxel in patients with refractory or recurrent endometrial papillary carcinoma. Determine the objective response and duration of response in patients treated with this regimen. Determine the acute side effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 12 weeks. PROJECTED ACCRUAL: Approximately 16-29 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
recurrent endometrial carcinoma, endometrial papillary serous carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Gitsch, MD
Organizational Affiliation
Allgemeines Krankenhaus - Universitatskliniken
Official's Role
Study Chair
Facility Information:
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Ospedale Mauriziano Umberto I
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Ospedale Civile
City
Voghera (PV)
ZIP/Postal Code
27058
Country
Italy
Facility Name
Hospitais da Universidade de Coimbra (HUC)
City
Coimbra
ZIP/Postal Code
3049
Country
Portugal
Facility Name
Hospital Universitasrio San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Queen Elizabeth Hospital
City
Gateshead
State/Province
England
ZIP/Postal Code
NE9 6SX
Country
United Kingdom

12. IPD Sharing Statement

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Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer

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