Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine

Overview

This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to incorporate second-line treatment into the study design. Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.

Full Title of Study: “Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

Interventions

  • Drug: Gemcitabine
    • Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28
  • Drug: Capecitabine
    • Capecitabine 2 x 1000 mg/m²/ d oral, d 1 – 14 followed by 7 days Pause (“Flat Dosing”)
  • Drug: Erlotinib
    • Erlotinib 150 mg/d oral, daily without break

Arms, Groups and Cohorts

  • Active Comparator: Arm A
  • Active Comparator: Arm B

Clinical Trial Outcome Measures

Primary Measures

  • TTF2
    • Time Frame: approximate 6 months after first line treatment
    • Time to treatment failure, after 2nd line (crossover) therapy

Secondary Measures

  • TTF1
    • Time Frame: approximate 6 months after randomization
    • Time to treatment failure
  • Remission Rate
    • Time Frame: approximate 6 months after randomization
  • Overall Survival
    • Time Frame: 42 months after randomization
  • Clinical Benefit Response
    • Time Frame: approximate 6 months after randomization
  • Tumor marker CA19-9 characteristics
    • Time Frame: approximate 6 months after randomization
  • Quality of Life
    • Time Frame: approximate 6 months after randomization
  • Toxicity
    • Time Frame: approximate 6 months after randomization

Participating in This Clinical Trial

Inclusion Criteria

  • Age between 18 and 75 years – Histologically proven pancreatic cancer stage III or IV (T1-3 N1M0 or T1 3N0 1M1) – No option for resection with curative intent – At least one measurable or not measurable lesion (according to RECIST) – No previous chemotherapy or other systemic tumor therapy – No previous radiation – Performance-Status 0-2 according to WHO/ECOG – Life expectancy of at least 3 months – Adequate kidney-, liver- and bone marrow function, defined as – Absolute neutrophil count * 1,5 x 109/l – Hemoglobin * 8 g/dl – Thrombocytes * 100 x 109/l – Bilirubin * 2 x upper norm (with liver mets < 5-fold) – Serum Creatinine * 1,25 x upper norm – Creatinine clearance > 30 ml/min (Cockroft/Gault) – Transaminases * 2,5 x upper norm (with liver mets < 5-fold) – Possibility of regular long-term follow-up – Negative pregnancy test in women at childbearing age – All patients must have signed an informed consent before study entry. Exclusion Criteria:

  • Known secondary cancer other than curatively treated basalioma or carcinoma in situ of the cervix uteri – Clinically unstable CNS-metastases – Known hypersensitivity against study medication – Severe impairment of renal function (creatinine clearance < 30 ml/min) – Severe impairment of liver function (bilirubin > 2,0 x above upper norm, transaminases > 2,5 x upper norm, or with known liver metastasis >5 x upper norm) – Clinically relevant disease of the cardiovascular system or other vital organs – Known polyneuropathy – Known DPD-deficiency (screening not required) – Simultaneous treatment with the antiviral agent sorivudin or chemically related agents such as brivudin – Pregnancy, lactation or lack of reliable contraception in women at childbearing age – Mental disease, drug- or alcohol abuse – Participation in another clinical trial within the last 4 weeks – All other diseases which may prevent adequate participation in the trial – Indication of lack of compliance with study regulations

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • PD Dr. med. Volker Heinemann
  • Collaborator
    • Roche Pharma AG
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: PD Dr. med. Volker Heinemann, Sponsor Delegatated Person – Ludwig-Maximilians – University of Munich
  • Overall Official(s)
    • Volker Heinemann, MD, Principal Investigator, University of Munich – Klinikum Grosshadern

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