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Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva Clinical research trials and Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva. Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva  Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva
Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva
For Condition: squamous cell carcinoma of the vulva,stage 4 vulvar cancer,recurrent vulvar cancer,stage 3 vulvar cancer
Status: 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 locally advanced, metastatic, or recurrent cancer of the vulva.
Details: OBJECTIVES: - Determine the therapeutic activity of paclitaxel in patients with locally advanced, metastatic, or recurrent squamous cell carcinoma of the vulva. - Determine the objective response rate and duration of response in these patients treated with this drug. - Determine the acute side effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 9 weeks. PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the vulva - Not suitable for radiotherapy or surgery as first-line treatment - Measurable or evaluable disease - At least 1 bidimensionally measurable target lesion - Measurable metastatic disease outside previously irradiated areas OR - Local recurrence within a previously treated area OR - Local lesions showing progression while on treatment - No brain metastasis PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-2 - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST/ALT less than 2 times upper limit of normal Renal: - Creatinine clearance greater than 60 mL/min Cardiovascular: - No prior or concurrent cardiac disease (i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the past year, cardiac ventricular arrhythmia requiring medication, or 2nd or 3rd degree heart block) Other: - No peripheral neuropathy greater than grade 1 - No serious active infection - No prior allergic reaction to drugs containing Cremophor EL - No other serious medical, psychological, familial, or social condition that would preclude study - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy except as concurrent therapy with radiotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - See Chemotherapy - No concurrent radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ElsWitteveen, , Academisch Ziekenhuis Utrecht
Academisch Ziekenhuis Utrecht *Recruiting*
Utrecht, , 3508 GA
Netherlands
Recruiting Contact Person 31-30-250-9111
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-20-566-9111
Ospedale di Circolo e Fondazione Macchi *Recruiting*
Varese, , 21100
Italy
Recruiting Contact Person 39-278-111
Western Infirmary *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting Contact Person 44-141-330-4006
Hospitais da Universidade de Coimbra (HUC) *Recruiting*
Coimbra, , 3001-301
Portugal
Recruiting Contact Person 351-39-403-939
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-332-211
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-3-821-3000
Centre Henri Becquerel *Recruiting*
Rouen, , 76038
France
Recruiting Contact Person 33-235-2320-82222
European Institute of Oncology *Recruiting*
Milano, , 20141
Italy
Recruiting Contact Person 39-2-574-891
Ospedale Civile *Recruiting*
Voghera, , 27058
Italy
Recruiting Contact Person 39-695-754
Ospedale Mauriziano Umberto I *Recruiting*
Torino, , 10128
Italy
Recruiting Contact Person 39-11-508-1111
Additional Information:
Study ID Numbers: CDR0000068565; EORTC-55985
Study Start Date:
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014599
Other Stage 4 Vulvar Cancer Studies:
1. Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva
2. Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva
3. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva
4. Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva
Related Studies:
Other stage 4 vulvar cancer Clinical Trials
Other Clinical Trials
Other Coimbra Clinical Trials
Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva
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