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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00022178 |
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Date of registration:
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10/08/2001 |
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Primary sponsor: |
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Public title:
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Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin
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Scientific title:
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An Open Label Prospective Randomised Study Comparing The Use Of Vincristine, Adriamycin And Cyclophosphamide (VAC) Versus Epirubicin, Cisplatin And Continuous 5-Flourouracil (ECF) In Patients With Unknown Primary Carcinoma (UPC) |
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Date of first enrolment:
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December 1998 |
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Target sample size:
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00022178 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Juan W. Valle, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Christie Hospital NHS Foundation Trust |
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Key inclusion & exclusion criteria
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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 as sole site of disease in female
patients No squamous cell carcinoma in cervical lymph nodes as sole site of disease in
male or female patients No neuroendocrine tumors No elevated alpha-fetoprotein, beta-HCG,
or PSA
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
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma of Unknown Primary
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Intervention(s)
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Drug: cisplatin
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Drug: cyclophosphamide
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Drug: doxorubicin hydrochloride
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Drug: epirubicin hydrochloride
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Drug: fluorouracil
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Drug: vincristine sulfate
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Secondary ID(s)
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CDR0000068792
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CHNT-VAC-VS-ECF
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EU-20041
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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