Status:
UNKNOWN
Paclitaxel/Carboplatin With or Without Cetuximab in CUP
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Neoplasms, Unknown Primary
Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether an addition of cetuximab to carboplatin/paclitaxel can improve efficacy in comparison to carboplatin/paclitaxel in patients with carcinoma of unknown-...
Detailed Description
Carcinomas of unknown primary (CUP) account for approximately 2-5% of all cancer diagnoses. Except for some subsets with favorable prognosis, for most of these patients, treatment options are limited,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00894569
Start Date
July 1 2009
End Date
August 1 2011
Last Update
May 14 2009
Active Locations (1)
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1
University Hospital Heidelberg, Med. Dep. v
Heidelberg, Germany, 69120