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

May 13, 2009 updated by: Heidelberg University

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg, Med. Dep. v
        • Contact:
        • Principal Investigator:
          • Alwin Kraemer, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy: Response rate, Median progression free survival (PFS), Overall survival (OS) Toxicity
Time Frame: until end of study
until end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

Merck KGaA, Darmstadt, Germany

Investigators

  • Principal Investigator: Alwin Kraemer, Prof. Dr., University of Heidelberg, Medic. Dep. V

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

July 1, 2010

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

May 6, 2009

First Submitted That Met QC Criteria

May 6, 2009

First Posted (Estimate)

May 7, 2009

Study Record Updates

Last Update Posted (Estimate)

May 14, 2009

Last Update Submitted That Met QC Criteria

May 13, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDRACT 2008-003174-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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