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

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ClinicalTrials.gov Identifier: NCT00440167
Recruitment Status : Unknown
Verified July 2012 by PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich.
Recruitment status was:  Active, not recruiting
First Posted : February 26, 2007
Last Update Posted : July 9, 2012
Roche Pharma AG
Information provided by (Responsible Party):
PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Drug: Capecitabine Drug: Erlotinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer
Study Start Date : June 2006
Actual Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Active Comparator: Arm A 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

Active Comparator: Arm B Drug: Gemcitabine
Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28

Drug: Erlotinib
Erlotinib 150 mg/d oral, daily without break

Primary Outcome Measures :
  1. TTF2 [ Time Frame: approximate 6 months after first line treatment ]
    Time to treatment failure, after 2nd line (crossover) therapy

Secondary Outcome Measures :
  1. TTF1 [ Time Frame: approximate 6 months after randomization ]
    Time to treatment failure

  2. Remission Rate [ Time Frame: approximate 6 months after randomization ]
  3. Overall Survival [ Time Frame: 42 months after randomization ]
  4. Clinical Benefit Response [ Time Frame: approximate 6 months after randomization ]
  5. Tumor marker CA19-9 characteristics [ Time Frame: approximate 6 months after randomization ]
  6. Quality of Life [ Time Frame: approximate 6 months after randomization ]
  7. Toxicity [ Time Frame: approximate 6 months after randomization ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440167

Sponsors and Collaborators
PD Dr. med. Volker Heinemann
Roche Pharma AG
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Principal Investigator: Volker Heinemann, MD University of Munich - Klinikum Grosshadern
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PD Dr. med. Volker Heinemann, Sponsor Delegatated Person, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00440167    
Other Study ID Numbers: RC-57 crossover
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012
Keywords provided by PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich:
pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors