|
Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin Clinical research trials and Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin. Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin clinical trial. Human subjects often obtain the finest healthcare possible for their Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin  Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin
Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin
For Condition: squamous cell carcinoma of unknown primary,undifferentiated carcinoma of unknown primary,newly diagnosed carcinoma of unknown primary,adenocarcinoma of unknown primary
Status: No longer recruiting
Sponsor(s): Christie Hospital N.H.S. Trust ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for metastatic cancer of an unknown site of origin. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic cancer of an unknown site of origin.
Details: OBJECTIVES: I. Compare the efficacy of the regimens, in terms of tumor response, progression-free survival, and overall survival of vincristine, doxorubicin, and cyclophosphamide vs epirubicin, cisplatin, and fluorouracil in patients with metastatic carcinoma of unknown primary. II. Compare the toxicity of these regimens in these patients. III. Compare quality of life and symptom control in patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to presence of liver metastases (yes vs no) and type of tumor (adenocarcinoma vs non-adenocarcinoma). Patients are randomized to one of two treatment arms. Arm I: Patients receive vincristine IV, doxorubicin IV, and cyclophosphamide IV on day 1. Arm II: Patients receive epirubicin IV and cisplatin IV over 4 hours on day 1 and fluorouracil IV continuously on days 1-21. Treatment in both arms repeats every 3 weeks for 3-6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the end of courses 2, 4, and 6, and 1 month after completion of therapy. Patients are followed at 1 month and then until death. PROJECTED ACCRUAL: A total of 398 patients (199 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic carcinoma of unknown primary; Adenocarcinoma or non-adenocarcinoma - No axillary lymph node metastases as sole site of disease in female patients - No peritoneal carcinomatosis in female patients - No squamous cell carcinoma in cervical lymph nodes - No neuroendocrine tumors - No elevated alpha-fetoprotein, beta-HCG, or PSA --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for carcinoma of unknown primary - Endocrine therapy: Not specified - Radiotherapy: Prior radiotherapy allowed except to sole site of measurable or evaluable disease; Concurrent palliative radiotherapy allowed except to sole site of measurable or evaluable disease - Surgery: Not specified - Other: No other concurrent experimental drugs --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: More than 3 months - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin less than 1.8 mg/dL - Renal: Creatinine less than 1.5 times upper limit of normal (ULN); Urea less than 1.5 times ULN; Glomerular filtration rate at least 60 mL/min - Cardiovascular: LVEF at least 50% by echocardiogram or MUGA scan; No uncontrolled angina pectoris; No heart failure; No clinically significant uncontrolled cardiac arrhythmias; No abnormal EKG - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 1 year after study; No other prior malignancy except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix; No medical or psychiatric condition that would preclude study; No other serious uncontrolled medical condition
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JuanValle, Study Chair, Christie Hospital N.H.S. Trust
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Additional Information:
Study ID Numbers: CDR0000068792; EU-20041,CHNT-VAC-VS-ECF
Study Start Date: December 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022178
Other Adenocarcinoma Of Unknown Primary Studies:
1. Radiation Therapy in Treating Patients With Metastases to the Lymph Nodes in the Neck From an Unknown Primary Tumor
2. Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin
3. Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin
4. Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary
5. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Cancer.
Related Studies:
Other adenocarcinoma of unknown primary Clinical Trials
Other England Clinical Trials
Other Manchester Clinical Trials
Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin
|
|
|
|
|
|
|
|
