Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
NCT ID: NCT00022620
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2001-06-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have refractory or recurrent endometrial cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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paclitaxel
Eligibility Criteria
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Inclusion Criteria
* 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
75 Years
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Gerald Gitsch, MD
Role: STUDY_CHAIR
Allgemeines Krankenhaus - Universitatskliniken
Locations
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Allgemeines Krankenhaus der Stadt Wien
Vienna, , Austria
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Ospedale Mauriziano Umberto I
Torino, , Italy
Ospedale Civile
Voghera (PV), , Italy
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , Portugal
Hospital Universitasrio San Carlos
Madrid, , Spain
Queen Elizabeth Hospital
Gateshead, England, United Kingdom
Countries
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Other Identifiers
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EORTC-55961
Identifier Type: -
Identifier Source: secondary_id
EORTC-55961
Identifier Type: -
Identifier Source: org_study_id