Clinical trial NCT00913198: A Study of CP-4126 in Patients With Advanced Pancreatic Cancer
Official title: A Phase II Study of CP-4126 in Patients With Advanced Pancreatic Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Adenocarcinoma of Pancreas
Keywords: Pancreas
Advanced adenocarcinoma
CP-4126
Lead sponsor: Clavis Pharma
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 21
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: The main objective of this study is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmed advanced pancreatic cancer\*
* Not eligible for curative resection
* Performance Status (ECOG) 0-2
* Estimated life expectancy of at least 12 weeks
* Age ≥ 18 years
* Adequate haematological and biological functions:

  * Neutrophils ≥ 1.5 x 109/L
  * Platelets \> 100.0 x 109/L
  * Hb ≥ 10 g/dL
  * AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN), if liver metastases
  * AST/ALT ≤ 5 x institutional ULN and ALP ≤ 4 x institutional ULN
  * Bilirubin ≤ 1.5 times institutional ULN, if liver metastases ≤ 3 x institutional ULN
  * Serum creatinine ≤ 1.5 times institutional ULN
* Signed informed consent

Exclusion Criteria:

* Prior chemotherapy for metastatic disease
* Symptomatic brain metastases
* Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
* Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
* History of allergic reactions to gemcitabine or egg
* Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
* Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
* Pregnant or breastfeeding women
* Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment
* Known positive status for HIV
* Any reason why, in the investigator's opinion, the patient should not participate in the study.
* Drug or alcohol abuse
* Prior radical resection, but exploratory laparotomy as well palliative (e.g bypass) surgery are allowed

Primary outcomes:
measure: Biological activity of CP-4126 in patients with advanced pancreatic cancer.
timeFrame: Every second cycle
Secondary outcomes:
measure: Overall survival, Objective response rate.
timeFrame: Every second cycle - study length
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique d'Oncologie Médicale, Institut Jules Bordet
city: Oslo
country: Norway
facility: Oslo University Hospital, The Norwegian Radium Hospital,
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål
Study officials:
References: