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Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer Clinical research trials and Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer. Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer  Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
For Condition: stage 4 endometrial cancer,recurrent endometrial cancer,stage 3 endometrial cancer
Status: Recruiting
Sponsor(s): EORTC Gynecological Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin and cisplatin are more effective with or without paclitaxel in treating endometrial cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced, metastatic, and/or relapsed endometrial cancer.
Details: OBJECTIVES: - Compare the overall survival of patients with locally advanced, metastatic, and/or relapsed endometrial cancer treated with doxorubicin and cisplatin with or without paclitaxel. - Compare the toxicity of these regimens in these patients. - Compare the progression-free survival of patients treated with these regimens. - Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (0 vs 1 vs 2), metastatic disease (yes vs no), prior pelvic radiotherapy for pelvic recurrence (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive doxorubicin IV over 30 minutes, paclitaxel IV over 3 hours, and cisplatin IV over 1 hour on day 1. - Arm II: Patients receive doxorubicin and cisplatin as in arm I. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each course, after courses 3 and 6, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, quality of life is assessed every 3 months. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 312 patients (156 per treatment arm) will be accrued for this study within 31 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed endometrial epithelial carcinoma with at least 1 of the following diagnoses: - Advanced metastatic and/or relapsed disease - Locally advanced inoperable or unresectable disease - No mixed mesodermal tumor and/or tumors showing evidence of sarcomatous elements - Uterine papillary serous carcinoma allowed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-2 Life expectancy - Not specified Hematopoietic - Neutrophil count greater than 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin greater than 10 g/dL (transfusions allowed) Hepatic - ALT and AST less than 2 times upper limit of normal (ULN) - Alkaline phosphatase less than 2 times ULN - Bilirubin < 1.5 times ULN Renal - Creatinine less than 1.5 times ULN - Creatinine clearance greater than 50 mL/min Cardiovascular - Normal baseline electrocardiogram - Normal baseline LVEF on MUGA Other - Able to tolerate high-dose dexamethasone - No uncontrolled infection - No other malignancy within the past 5 years except successfully treated basal cell skin cancer or carcinoma in situ of the cervix - No prior nervous or psychiatric disorder that would preclude study participation - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 12 months since prior adjuvant chemotherapy - Total dose of doxorubicin 200 mg/m^2 - Total dose of epirubicin 300 mg/m^2 Endocrine therapy - At least 28 days since prior hormonal therapy for patients with partial or complete response after first line treatment Radiotherapy - No prior radiotherapy to any area other than pelvis Surgery - Not specified Other - No other concurrent anticancer medications
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NicholasReed, , University of Glasgow
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-541-3111
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-33-2211
Centre Regional Francois Baclesse *Recruiting*
Caen, , 14076
France
Recruiting Contact Person 33-231-45-5000
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-821-3000
Algemeen Ziekenhuis Middelheim *Recruiting*
Antwerp, , 2020
Belgium
Recruiting Contact Person 32-280-3111
Centre Leon Berard *Recruiting*
Lyon, , 69373
France
Recruiting Contact Person 33-478-782-828
Ospedale di Circolo e Fondazione Macchi *Recruiting*
Varese, , 21100
Italy
Recruiting Contact Person 39-278-111
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-526-911
I.R.C.C.S. Policlinico San Matteo *Recruiting*
Pavia, , 27100
Italy
Recruiting Contact Person 39-502-640
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-566-9111
Additional Information:
Study ID Numbers: CDR0000258154; EORTC-55984
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052312
Other Stage 3 Endometrial Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
2. Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
3. Liposomal Doxorubicin in Treating Patients with Advanced or Recurrent Endometrial Cancer
4. Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer
5. Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors
Related Studies:
Other stage 3 endometrial cancer Clinical Trials
Other Clinical Trials
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Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
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