Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00022620
First received: August 10, 2001
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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: 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:

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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022620

Locations
Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, A-1090
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Italy
Ospedale Mauriziano Umberto I
Torino, Italy, 10128
Ospedale Civile
Voghera (PV), Italy, 27058
Portugal
Hospitais da Universidade de Coimbra (HUC)
Coimbra, Portugal, 3049
Spain
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
Investigators
Study Chair: Gerald Gitsch, MD Allgemeines Krankenhaus - Universitatskliniken
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00022620     History of Changes
Other Study ID Numbers: EORTC-55961, EORTC-55961
Study First Received: August 10, 2001
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Cystadenocarcinoma, Serous
Cystadenocarcinoma
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Cystic, Mucinous, and Serous
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014