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CompletedNCT00022620Updated Sep 24, 2012

Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer

A Phase 2 interventional study of paclitaxel in Endometrial Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 8 sites in 6 countries. Open to female participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2012-09-24.

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
Up to 75 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Endometrial Cancer

Keywords

  • recurrent endometrial carcinoma
  • endometrial papillary serous carcinoma
03

In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

Browse Endometrial Neoplasms studies →

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 75 Years
Sexes eligible
Female
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • Drugpaclitaxel
06

Study locations

8 sites
  • Allgemeines Krankenhaus der Stadt Wien
    Vienna, A-1090, Austria
  • Universitair Ziekenhuis Antwerpen
    Edegem, B-2650, Belgium
  • U.Z. Gasthuisberg
    Leuven, B-3000, Belgium
  • Ospedale Mauriziano Umberto I
    Torino, 10128, Italy
  • Ospedale Civile
    Voghera (PV), 27058, Italy
  • Hospitais da Universidade de Coimbra (HUC)
    Coimbra, 3049, Portugal
  • Hospital Universitasrio San Carlos
    Madrid, 28040, Spain
  • Queen Elizabeth Hospital
    Gateshead, England NE9 6SX, United Kingdom
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00022620
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Jun 2001
Primary completion
Oct 2002
Last update
Sep 24, 2012

Study contacts

Gerald Gitsch, MD
study chair · Allgemeines Krankenhaus - Universitatskliniken
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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