Paclitaxel/Carboplatin With or Without Cetuximab in CUP

• Status: Unknown status
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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-primary.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cetuximab; Paclitaxel

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