Paclitaxel/Carboplatin With or Without Cetuximab in CUP (PACET-CUP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Heidelberg University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck KGaA
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00894569
First received: May 6, 2009
Last updated: May 13, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Neoplasms, Unknown Primary
Carcinoma
Drug: paclitaxel/carboplatin
Drug: cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Labeled, Randomized Multi-Center Phase II Study Evaluating the Efficacy and Safety of Paclitaxel/ Carboplatin With and Without Cetuximab as First-Line Treatment of Adeno- and Undifferentiated Carcinoma of Unknown Primary (CUP)

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • 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. [ Time Frame: 8 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Response rate, Median progression free survival (PFS), Overall survival (OS) Toxicity [ Time Frame: until end of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: July 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
6 cycles of carboplatin/paclitaxel
Drug: paclitaxel/carboplatin
6 cycles paclitaxel 175 mg/m² and carboplatin AUC 5, repetition d22.
Experimental: B
carboplatin/paclitaxel plus cetuximab until disease progression
Drug: paclitaxel/carboplatin
6 cycles paclitaxel 175 mg/m² and carboplatin AUC 5, repetition d22.
Drug: cetuximab
cetuximab (400 mg/m² first dose, 250 mg/m² weekly) until disease progression

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, and no standard first-line regimen has been identified. Standard therapy for patients with adeno- or undifferentiated CUP is Paclitaxel/Carboplatin, yielding response rates between 20-40%. In recent years, targeted therapies with inhibitors to EGFR, several tyrosine kinases, and VEGF have been shown to improve survival in different solid tumor entities. Cetuximab, a monoclonal antibody against the EGF receptor, has proved efficacy in combination with chemotherapy in patients with metastatic colorectal cancer, gastric cancer, squamous cell carcinoma of head and neck and non-small cell lung cancer (NSCLC). Because of these promising results it seems to be reasonable to examine the impact of adding cetuximab to standard chemotherapy with paclitaxel and carboplatin in patients with CUP.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894569

Contacts
Contact: Alwin Kraemer, Prof. +49-6221-42-1441 a.kraemer@dkfz.de
Contact: Katharina Schuette, Dr. +49-351-458-2311 katharina.schuette@uniklinikum-dresden.de

Locations
Germany
University Hospital Heidelberg, Med. Dep. v Not yet recruiting
Heidelberg, Germany, 69120
Contact: Kraemer    +49-6221-42-1441    a.kraemer@dkfz.de   
Principal Investigator: Alwin Kraemer, Prof. Dr.         
Sponsors and Collaborators
Heidelberg University
Merck KGaA
Investigators
Principal Investigator: Alwin Kraemer, Prof. Dr. University of Heidelberg, Medic. Dep. V
  More Information

No publications provided

Responsible Party: Prof. Dr. Alwin Krämer, University Heidelberg
ClinicalTrials.gov Identifier: NCT00894569     History of Changes
Other Study ID Numbers: EUDRACT 2008-003174-18
Study First Received: May 6, 2009
Last Updated: May 13, 2009
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Heidelberg University:
carcinoma of unknown primary
cancer of unknown primary
CUP
carboplatin
paclitaxel
cetuximab

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Cetuximab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014