adeno- and undifferentiated Carcinoma of Unknown Primary (CUP)
Conditions
Interventions
Trade Name: Erbitux
Product Name: NA
Product Code: NA
Pharmaceutical Form:
Trade Name: Taxol
Product Name: NA
Product Code: NA
Pharmaceutical Form:
INN or Proposed INN: Paclitaxel
Other descriptive
Paclitaxel-ratiopharm®
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: up to
Concentration number: 0-175
Trade Name: Carboplatin
Product Name: NA
Product Code: NA
Pharmaceutic
Carboplatin-ratiopharm®-10 mg/ml
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: AUC5-AUC5
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or cytologically proven, non-resectable carcinoma of unknown primary (adenocarcinoma or non-differentiated carcinoma) -Measurable tumor lesion(s) according to RECIST criteria -WHO PS 0 to 1 -Signed written informed consent -=18 years of age -Effective contraception for both male and female subjects if the risk of conception exists -Adequate bone marrow function: Neutrophil blood cell count (NBC) = 1,5x109/L, platelet count = 100x109/L, hemoglobin = 5,00 mmol/L (8 g/dL) -Adequate liver and renal function: bilirubin = 1,5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks, ASAT and ALAT = 2,5 x UNL or in case of liver metastases = 5 x UNL. Serum creatinine = 1.5 x UNL 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 criteria
Exclusion criteria: -Previous exposure to epidermal growth factor receptor-targeting therapy -Previous chemotherapy except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment -Radiotherapy (> 30 Gy) major abdominal or thoracic surgery within the last 4 weeks before inclusion -Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy. -Investigational agents or participation in clinical trials within 30 days before treatment start in this study -Clinically relevant coronary disease or myocardial infarction within 12 months before study entry -Possibility of a curative local treatment (surgery and/or radiotherapy) -Women with axillary node metastasis as predominant tumor site -Women with peritoneal carcinomatosis as predominant tumor site -Men CTC grade I -Previous malignancy within the last 5 years (except history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment) -History of severe psychiatric illness -Life expectancy less than six weeks -Drug or alcohol abuse -Known hypersensitivity reaction to any of the components of the study treatment -Pregnancy (absence to be confirmed by ß-hCG test) or lactation period -Brain metastasis and/or leptomeningeal disease (known or suspected) -Acute or sub-acute intestinal occlusion or inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: -Response rate (RR) -Toxicity -Median progression free survival (PFS) -Overall survival (OS) -Rate of secondary diagnosed primary tumors by histopathology -Prognostic and predictive value of results of translational research (including EGFR-, ERCC1-, RRM1-, and TTF1-expression levels, k-ras mutation status, genomic profiling) with regard to treatment efficacy ;Primary end point(s): The rate of progression free survival at 8 months after randomization, defined as the proportion of patients alive with stable disease, partial or complete response, according to RECIST is the primary endpoint for the final analysis. ;Main Objective: To evaluate the progression free survival rate with Cetuximab/ Paclitaxel/ Carboplatin vs. Paclitaxel/ Carboplatin in patients with carcinoma of unknown primary | — |
Countries
Germany
Outcome results
None listed