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Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 27, 2003
Last Update Posted: September 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition Intervention Phase
Endometrial Cancer Drug: paclitaxel Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)

Resource links provided by NLM:

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Study Start Date: June 2001
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 75 and under

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • Neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than 50 umol/L


  • BUN no greater than 8.0 mmol/L
  • Creatinine no greater than 120 umol/L
  • Creatinine clearance at least 60 mL/min


  • 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


Biologic therapy:

  • Not specified


  • 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


  • 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)


  • Prior surgical management of lymph nodes allowed
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022620

Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, A-1090
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Ospedale Mauriziano Umberto I
Torino, Italy, 10128
Ospedale Civile
Voghera (PV), Italy, 27058
Hospitais da Universidade de Coimbra (HUC)
Coimbra, Portugal, 3049
Hospital Universitasrio San Carlos
Madrid, Spain, 28040
United Kingdom
Queen Elizabeth Hospital
Gateshead, England, United Kingdom, NE9 6SX
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Gerald Gitsch, MD Allgemeines Krankenhaus - Universitatskliniken
  More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00022620     History of Changes
Other Study ID Numbers: EORTC-55961
First Submitted: August 10, 2001
First Posted: January 27, 2003
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
recurrent endometrial carcinoma
endometrial papillary serous carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action