A multi-centre phase II trial to assess the efficacy of epirubicin, cisplatin and capecitabine incorporating the prospective validation of molecular classifiers and exploratory metabonomics. - CUP ONE
- Conditions
- Metastatic Carcinomas of Unknown Primary origin (CUP)
- Registration Number
- EUCTR2008-000657-35-GB
- Lead Sponsor
- Greater Glasgow and Clyde Health Board (GGCHB)/University of Glasgow
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 59
INCLUSION - TRANSLATIONAL PART
1. Uncertain or unknown primary site of origin of malignancy
2. Histologically confirmed carcinomas (adenocarcinomas, SCC & undifferentiated are all acceptable) from tru-cut biopsy and/ or operative procedure
- lymphomas, sarcomas, germ-cell tumours are not intended to be either part of this trial, if uncertain or equivocal they can be discussed with the TMG
- Cytologically confirmed carcinomas, in which a primary cannot be found following appropriate investigations (see below), can be offered the study only if either a subsequent tru-cut biopsy and/or operative procedure is to be performed at some stage of the patients investigations or surgical treatment (such as debulking or bypass surgery). Written informed consent is required for both parts separately.
INCLUSION - CLINICAL TRIAL
1. Histologically or cytologically confirmed carcinomas, in which a primary cannot be conclusively identified following appropriate investigations and discussion in the appropriate MDM (see 4.1 above).
- Lymphomas, sarcomas and germ-cell tumours are not intended to be part of this trial, if uncertain or equivocal they can be discussed with the TMG
- Cytologically confirmed carcinomas, in which a primary cannot be found following appropriate investigations (see 4.3 below), can be offered both parts of the study only if either a subsequent tru-cut biopsy and/or operative procedure is to be performed at some stage of the patient’s investigations or surgical treatment (such as debulking or bypass surgery). Written informed consent is required for both parts separately.
- If only cytological confirmation from a FNA is possible, only the second part of the study can be considered.
2. Inoperable metastatic carcinoma with at least unidimensional measurable disease.
3. Age > 18 years
4. Performance status < 2
5. Life expectancy >12 weeks
6. Adequate haematological function: absolute neutrophil count > 2.0 x 109/l, white cell count > 3.0 x 109/l, platelets > 100 x 109/l
7. Adequate renal function: serum creatinine < 120?m/l and creatinine clearance > 50 ml/min
8. Adequate hepatic function: bilirubin within 2x normal range, AST or ALT > 5 times the upper limit of normal
9. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
EXCLUSION - TRANSLATIONAL
1. Significant intercurrent medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to give informed consent
2. Non-carcinoma histology (lymphomas, sarcomas and germ-cell tumours are not intended to be part of this trial; if equivocal discuss with TMG)
EXCLUSION - CLINICAL TRIAL
1. Previous chemotherapy
2. Co-existent second malignancy or history of prior malignancy within 5 years, except for adequately treated basal cell carcinoma and non-invasive carcinoma of the cervix. If history of prior malignancy within 10 years, the previous histology should be compared and available for central review.
3. Pregnant or lactating women. Women of child bearing potential not prepared to use effective contraception
4. Significant intercurrent medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to give informed consent or tolerate the therapy
5. Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with a clinically significant abnormal ECG or cardiac history having a LVEF of lower limit of normal range for institution as determined by MUGA scan or echocardiogram.
6. The presence of proven cerebral metastases
7. Any chemotherapy, hormonal or immunotherapy or other investigational drug within the preceding 4 weeks (steroids are permissible).
8. Previous radiotherapy is allowed but not to sites of assessable disease. No chemotherapy is to be given until resolution of all acute radiotherapy effects or a minimum of 6 weeks has elapsed since end of radiotherapy. Radiosensitisation with chemotherapy during radiotherapy is not allowed.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: Translational: To select the molecular classifier with the highest diagnostic accuracy<br><br> Clinical Trial: To estimate the response rate from the ECX regimen<br> ;<br> Secondary Objective: Clinical Trial<br> 1. Progression-free survival<br> 2. Overall survival<br> 3. Cost-utility comparison of diagnostic molecular classifiers with average clinical diagnostic work-up<br> 4. Correlation of molecular profiles with patient outcome<br> 5. Identification of potential prognostic metabonomic signatures to efficacy & toxicity profiles<br> ;<br> Primary end point(s): For the translational part the primary objective is to select the molecular classifier with the highest diagnostic accuracy.<br><br> For the clinical trial part the primary objective is to estimate the response rate with ECX.<br>
- Secondary Outcome Measures
Name Time Method