Phase II trial of Erlotinib in combination with increasing dose of gemcitabine given as fixed dose rate infusion in advanced pancreatic cancer. - tarcevapancreas

• Conditions: Patients with unresectable advanced or metastatic pancreatic cancer; MedDRA version: 6.1Level: PTClassification code 10033609

• Registration Number: EUCTR2006-001238-41-IT
• Lead Sponsor: AZIENDA OSPEDALIERA POLICLINICO DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Histologically confirmed unresectable advanced or metastatic pancreatic adenocarcinoma

-Measurable or evaluable disease. To be considered evaluable for complete or partial response patients must have at least one measurable lesion.

-age 18-70 yrs

-PS 0-1 (ECOG scale)

-No previous chemotherapy for advanced/metastatic pancreatic carcinoma. Previous adjuvant treatment is allowed.

-Patients must have no uncontrolled concurrent serious medical illness.

-Investigations including chest x-ray, CT scan of abdomen and pelvis and other scans (as clinically indicated), have to be performed within 28 days prior to start the treatment.

-Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to start the treatment:

ANC> 1500/l

PLT> 100000/l

Creatinine< 1.5 times the ULN

Total Bilirubine< 2 times the ULN

GOT< 2 times the ULN or < 5 times in case of liver metastasis

GPT< 2 times the ULN or < 5 times in case of liver metastasis

-Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-history of malignancies in the last 5 years

-significant history of cardiac disease, uncontrolled high blood pressure, instable angina, congestive heart failure, myocardial infarction within the last year.

-Serious active infection or serious underling medical conditions

-Known CNS metastases. CT scan of brain is not required unless there is clinical suspicion of CNS involvement

-GI tract disease resulting in an inability to take oral medication or a requirement of IV alimentation, prior surgery procedure affecting absorption, uncontrolled inflammatory GI disease

-Serious active infection or serious underlying medical conditions that would impair the ability of the patient to receive the treatment.

-Prior treatment with inhibitors of EGFR

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the feasibility and the toxicity of increasing doses of Gemcitabine given as fixed dose rate infusion of 10 mg/m2/min every 2 weeks in combination with Erlotinib.;Secondary Objective: -Activity of the treatment in terms of objective response rate (partial response and complete response)<br><br>-Efficacy: progression-free and overall survival;Primary end point(s): Primary<br><br>-MTD of Gemcitabine given as fixed dose rate infusion given in combination with Erlotinib <br><br>Biological<br><br>-When tumor tissue available before and after at least 4 courses of treatment: EGFR, EGFR gene copy number (FISH), p-EGFR, p-MAPK, p-Akt, p21, EGFR mutation (exons 18, 19, 21), VEGFR