A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Placebo; Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00674973

BO21129

2007-003738-40 (EudraCT Number)

Details and patient eligibility

About

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
• measurable disease according to RECIST;
• failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
• ECOG performance status of 0-2.

Exclusion criteria

• local or locally advanced-resectable pancreatic cancer;
• any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
• major surgery within 2 weeks prior to randomization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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207 participants in 2 patient groups, including a placebo group

Erlotinib

Experimental group

Description:

Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.

Treatment:

Drug: Erlotinib

Placebo

Placebo Comparator group

Description:

Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.

Treatment:

Drug: Placebo