Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma

Metastatic Pancreatic Cancer Clinical Trial

— GEMOXEL  

Official title:

Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744640
• Other study ID #: EK-Nr. 92/05
• Secondary ID: 2005DR2296
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 29, 2008
• Last updated: January 11, 2010
• Start date: October 2005
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer (APC). Recent randomized trials have shown increased clinical benefit with the addition of oxaliplatin and prolonged median survival with the addition of capecitabine to gemcitabine. Gemcitabine, capecitabine and oxaliplatin are 3 newer, well tolerated anticancer drugs with mild and non-overlapping toxicity profiles. We therefore propose a dose-finding and safety study of the triple combination gemcitabine, capecitabine and oxaliplatin in patients with APC (Phase I part), followed by a phase II part to assess preliminary efficacy of this triple combination.

Description:

Primary Objectives:

• Phase I: to determine the maximum tolerated dose (MTD) of oxaliplatin in combination with gemcitabine and capecitabine (GEMOXEL) in patients with APC

• Phase II: to assess any anti-tumor activity of GEMOXEL in patients with APC

Secondary Objectives:

• to assess toxicity and safety of the combination treatment GEMOXEL in patients with APC

Primary Endpoints:

• Phase I: Dose-limiting toxicity

• Phase II: Objective tumor response

Secondary Endpoints:

• Toxicity at MTD according to NCI CTC 3.0

• Progression-free survival and Overall Survival

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cytologically or histologically confirmed adenocarcinoma of the exocrine pancreas

• Disease non-resectable and locally advanced or metastatic

• Measurable disease or evaluable disease i.e. tumor marker CA19-9 at baseline = 1.5 x upper limit of normal (ULN)

• Age >18 years

• Karnofsky performance status = 60%

• Life expectancy of at least 3 months

• Written informed consent

• Willing and able to comply with the protocol for the duration of the study

Exclusion Criteria:

• Prior chemotherapy for pancreatic cancer

• Prior adjuvant radio- or radiochemotherapy for pancreatic cancer within 12 months of inclusion

• Known CNS metastases at the time of enrollment

• Neutrophil count = 1.5 x109/l, platelet count =100 x109/l, hemoglobin = 10g/dl

• Serum creatinine > 1.25 x ULN

• ASAT, ALAT and alkaline phosphatase > 2.5 ULN or > 5 ULN in the presence of liver metastasis, Bilirubin > 1.5 ULN (after treatment of obstructive jaundice eg. stent)

• Pregnant or breast feeding women (women of childbearing potential must have a negative pregnancy test at baseline)

• Men and women of reproductive potential who are not using an effective method of contraception

• Clinically significant cardiac disease (NYHA III-IV) or myocardial infarction within the last 12 months

• Neurological disease with dys-/paraesthesias > grade 1 according to NCI CTC

• Any serious concomitant disorder incompatible with the trial (in the judgement of the investigator)

• Psychiatric disability thought to be clinically significant in the opinion of the investigator precluding informed consent or interfering with compliance

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Cancer
• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine, oxaliplatin, capecitabine
gemcitabine day 1 and 8, oxaliplatin day 1, capecitabine days 1-14, q3weeks

Locations

Country	Name	City	State
Switzerland	St. Clara Hospital	Basel
Switzerland	University Hospital Basel	Basel
Switzerland	Cantonal Hospital Bruderholz	Bruderholz	BL
Switzerland	Cantonal Hospital Liestal	Liestal	BL
Switzerland	Cantonal Hospital Lucerne	Lucerne
Switzerland	City Hospital Triemli	Zurich
Switzerland	Oncocenter Hirslanden	Zurich
Switzerland	University Hospital	Zurich

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Roche Pharma AG, Sanofi, Swiss Cancer League, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		6 weeks	No
Secondary	Progression-free survival and overall survival		3 months	No