Clinical trial NCT00885066: Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
Official title: Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: stage III pancreatic cancer
stage IV pancreatic cancer
adenocarcinoma of the pancreas
recurrent pancreatic cancer
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2009-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.

Detailed description: OBJECTIVES:

Primary

* Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.

Secondary

* Analyze the limiting toxicities according to CTC.
* Analyze the toxicity according to CTC.
* Determine the recommended dose.
* Determine the pharmacokinetic dosages of the three drugs.
* Analyze interactions between the drugs.

OUTLINE: This is a multicenter study.

Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the pancreas

  * Advanced disease
* No standard curative therapy available
* Must have received prior first-line chemotherapy
* No brain metastasis

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy ≥ 8 weeks
* ANC ≥ 1.5 x 10\^9/ L
* Platelet count ≥ 130 x 10\^9/ L
* Hemoglobin ≥ 10 g/dL
* Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 130 mmol/L OR creatinine clearance \> 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No intolerance or hypersensitivity to any of the drugs being tested
* No history of interstitial lung disease
* No history of severe cardiac disease
* No serious uncontrolled infection
* No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome
* Must not be deprived of liberty or under guardianship
* Must not be on probation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior erlotinib hydrochloride
* No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4
* More than 14 days since participation in another clinical trial

Primary outcomes:
measure: Clinical or laboratory toxicities as assessed by CTC
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
affiliation: Centre Antoine Lacassagne
name: Eric Francois
role: PRINCIPAL_INVESTIGATOR
References: