Brief Title
Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
Official Title
Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)
Brief 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.
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Endometrial Cancer
Intervention
paclitaxel
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
June 2001
Primary Completion Date
October 2002
Eligibility 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
Gender
Female
Ages
N/A - 75 Years
Accepts Healthy Volunteers
No
Contacts
Gerald Gitsch, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00022620
Organization ID
EORTC-55961
Secondary IDs
EORTC-55961
Responsible Party
Sponsor
Study Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor
Gerald Gitsch, MD, Study Chair, Allgemeines Krankenhaus - Universitatskliniken
Verification Date
September 2012