Clinical trial NCT00744640: Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma
Official title: Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Locally Advanced Pancreatic Cancer
Metastatic Pancreatic Cancer
Keywords: advanced pancreatic cancer
palliative chemotherapy
first-line therapy
capecitabine
oxaliplatin
gemcitabine
dose-finding study
Phase II
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Swiss Cancer League
name: Roche Pharma AG
name: Sanofi
First posted: 2008-09-01
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Progression-free survival and overall survival
timeFrame: 3 months
Other outcomes:
Locations:
city: Bruderholz
country: Switzerland
facility: Cantonal Hospital Bruderholz
state: BL
city: Liestal
country: Switzerland
facility: Cantonal Hospital Liestal
state: BL
city: Basel
country: Switzerland
facility: St. Clara Hospital
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Lucerne
country: Switzerland
facility: Cantonal Hospital Lucerne
city: Zurich
country: Switzerland
facility: City Hospital Triemli
city: Zurich
country: Switzerland
facility: Oncocenter Hirslanden
city: Zurich
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Viviane Hess, MD
role: PRINCIPAL_INVESTIGATOR
References: