- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00022620
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.
Study Overview
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 Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, A-1090
- Allgemeines Krankenhaus der Stadt Wien
-
-
-
-
-
Edegem, Belgium, B-2650
- Universitair Ziekenhuis Antwerpen
-
Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
-
-
-
-
-
Torino, Italy, 10128
- Ospedale Mauriziano Umberto I
-
Voghera (PV), Italy, 27058
- Ospedale Civile
-
-
-
-
-
Coimbra, Portugal, 3049
- Hospitais da Universidade de Coimbra (HUC)
-
-
-
-
-
Madrid, Spain, 28040
- Hospital Universitasrio San Carlos
-
-
-
-
England
-
Gateshead, England, United Kingdom, NE9 6SX
- Queen Elizabeth Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Gerald Gitsch, MD, Allgemeines Krankenhaus - Universitatskliniken
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endometrial Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- EORTC-55961
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Endometrial Cancer
-
Assistance Publique - Hôpitaux de ParisUniversité Montpellier; Ecole d'econmie de Paris (PSE)-Hospinnomics; Université...CompletedEndometrial Cancer Stage I | Endometrial Cancer Stage IIFrance
-
Radboud University Medical CenterMaastricht University Medical Center; Erasmus Medical Center; Catharina Ziekenhuis... and other collaboratorsRecruitingEndometrial Cancer Recurrent | Endometrial Cancer Stage III | Endometrial Cancer Stage IVNetherlands
-
Batman Training and Research HospitalEskisehir Osmangazi UniversityCompletedGynecologic Cancer | Endometrial Cancer Stage
-
Samsung Medical CenterRecruitingEndometrial Cancer Stage IKorea, Republic of
-
Duke UniversityDuke Cancer InstituteCompleted
-
Far Eastern Memorial HospitalCompletedOutcome of Endometrial CancerTaiwan
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingAdvanced Endometrial CancerChina
-
Novartis PharmaceuticalsCompletedAdvanced Endometrial CancerBelgium, France, Italy, Canada, Spain, Australia, Germany, United States, Japan, Brazil, Singapore, Russian Federation, Poland
-
Masonic Cancer Center, University of MinnesotaCompletedCervical Cancer | Ovarian Cancer | Uterine Endometrial CancerUnited States
-
Rambam Health Care CampusCompletedSerous Papillary Endometrial CancerIsrael
Clinical Trials on paclitaxel
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Breast Carcinoma | Stage IV Breast Cancer AJCC v6 and v7 | Stage III Breast Cancer AJCC v7 | Stage IIIA Breast Cancer AJCC v7 | Stage IIIB Breast Cancer AJCC v7 | Stage IIIC Breast Cancer AJCC v7 | Metastatic Breast Carcinoma | Locally Advanced Breast CarcinomaUnited States
-
Hutchison Medipharma LimitedSun Yat-sen UniversityActive, not recruitingAdvanced Gastric CancerChina
-
University of WashingtonNational Cancer Institute (NCI); Celgene CorporationCompletedRecurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung CancerUnited States
-
Anne NoonanNational Cancer Institute (NCI)RecruitingStage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic AdenocarcinomaUnited States
-
Shengjing HospitalRecruiting
-
CTI BioPharmaTerminatedNSCLCUnited States, Canada, Bulgaria, Romania, Russian Federation, Ukraine, Mexico, Argentina, Hungary, Poland, United Kingdom
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnRecurrent Bladder Urothelial Carcinoma | Stage IV Bladder Urothelial CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
CTI BioPharmaTerminated
-
Novartis PharmaceuticalsCompletedMetastatic or Locally Advanced Solid TumorsNetherlands, Spain, Germany, Switzerland, Belgium