Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT00894569
Eligibility Criteria:
Inclusion Criteria:
* Histologic or cytologic 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
* Paclitaxel/Carboplatin with or without Cetuximab in Adeno- and Undifferentiated CUP (PACET-CUP)
* 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:
* Neutrophiles 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
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 or 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 \< 50 years old with retroperitoneal or mediastinal lymph node +/- lung metastases as predominant tumor site
* Identification of the primary or suspicion of a specific tumor entity by reference histopathology (i.e., Her-2 positive or hormone receptor positive tumors corresponding to breast cancer, CK7-negative/CK20- positive tumors with high probability for colorectal cancer)
* Peripheral neuropathy \> 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 β-hCG test) or lactation period
* Brain metastasis and/or leptomeningeal disease (known or suspected)
* Acute or sub-acute intestinal occlusion or inflammatory bowel disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00894569
Study Brief:
Protocol Section:
NCT00894569