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Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer Clinical research trials and Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer. Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer  Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
For Condition: endometrial papillary carcinoma,recurrent endometrial cancer
Status: No longer recruiting
Sponsor(s): EORTC Gynecological Cancer Cooperative Group ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeraldGitsch, Study Chair, Allgemeines Krankenhaus der Stadt Wien
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Ospedale Civile
Voghera (PV), , 27058
Italy
Ospedale Mauriziano Umberto I
Torino, , 10128
Italy
Hospital Universitasrio San Carlos
Madrid, , 28040
Spain
Allgemeines Krankenhaus der Stadt Wien
Vienna, , A-1090
Austria
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , 3049
Portugal
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Queen Elizabeth Hospital
Gateshead, England, NE9 6SX
United Kingdom
Additional Information:
Study ID Numbers: CDR0000068835; EORTC-55961
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022620
Other Recurrent Endometrial Cancer Studies:
1. Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With Endometrial Cancer
2. Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
5. Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Related Studies:
Other recurrent endometrial cancer Clinical Trials
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Other Torino Clinical Trials
Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
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