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Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
This study is ongoing, but not recruiting participants.
Study NCT00022620   Information provided by National Cancer Institute (NCI)
First Received: August 10, 2001   Last Updated: July 23, 2008   History of Changes

August 10, 2001
July 23, 2008
June 2001
 
 
 
Complete list of historical versions of study NCT00022620 on ClinicalTrials.gov Archive Site
 
 
 
Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)

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.

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.

Phase II
Interventional
Treatment, Open Label
Endometrial Cancer
Drug: paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Female
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Italy,   Portugal,   Spain,   United Kingdom
 
NCT00022620
 
CDR0000068835, EORTC-55961
European Organization for Research and Treatment of Cancer
 
Study Chair: Gerald Gitsch, MD Allgemeines Krankenhaus - Universitatskliniken
National Cancer Institute (NCI)
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP