Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022620
• Other study ID #: EORTC-55961
• Secondary ID: EORTC-55961
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2001
• Last updated: September 20, 2012
• Start date: June 2001

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer

Intervention

Drug:
• paclitaxel

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus der Stadt Wien	Vienna
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
Italy	Ospedale Mauriziano Umberto I	Torino
Italy	Ospedale Civile	Voghera (PV)
Portugal	Hospitais da Universidade de Coimbra (HUC)	Coimbra
Spain	Hospital Universitasrio San Carlos	Madrid
United Kingdom	Queen Elizabeth Hospital	Gateshead	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  Italy,  Portugal,  Spain,  United Kingdom,