Tarceva and Capecitabine for Pancreatic Cancer

NCT ID: NCT00125021

Last Updated: 2009-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2008-09-30

Brief Summary

This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating patients with metastatic pancreatic cancer.

Detailed Description

Patients will be treated once daily with Tarceva, twice daily with capecitabine for 14 consecutive days, followed by 7 days off of capecitabine (a cycle is 21 days). At week 1 of each cycle a physical exam and blood work will be performed. Reassessment of tumor size will be conducted at 6 weeks (2 cycles), 12 weeks (4 cycles) and then every 9 weeks thereafter. Patients will remain on treatment until one of the following occur: disease progression, illness that prevents further treatment or unacceptable adverse events.

Conditions

Pancreatic Cancer; Neoplasm Metastasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Capecitabine

Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).

Intervention Type: DRUG

OSI-774

Given once daily

Intervention Type: DRUG

Other Intervention Names

Tarceva

Eligibility Criteria

Inclusion Criteria

• Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors)
• Only patients with measurable disease
• ECOG performance status < or equal to 1
• Life expectancy >12 weeks
• Signed informed consent
• Failed or intolerance to first-line therapy for metastatic disease with a gemcitabine-containing regimen. Patients may have received adjuvant therapy in addition to one prior regimen for metastatic disease.
• >4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities
• >4 weeks must have elapsed from the participation in any investigational drug study
• Laboratory values:

• ANC > 1500/mm3;
• Hemoglobin > 9.0 gm/dl;
• Platelets > 100,000/mm3;
• SGOT <2.5 X upper limit of normal; or <5 X upper limit of normal if evidence of liver metastases; Alkaline phosphatase < 2.5 X upper limit of normal; or < 5 X upper limit of normal if evidence of liver metastases; Total bilirubin < 1.5 X upper limit of normal; Creatinine clearance > 50 cc/min (by Cockroft - Gault or as determined from a 24-hour urine collection).

Exclusion Criteria

• Prior therapy with capecitabine or epidermal growth factor receptor (EGFR) inhibitors
• More than one prior chemotherapy treatment regimen for metastatic disease
• Clinically apparent central nervous system (CNS) metastases or carcinomatous meningitis
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or heart attack within the last 12 months).
• Major surgery within 4 weeks of the start of study treatment, without complete recovery.
• Evidence of CNS metastases (unless CNS metastases have been stable for > 3 months) or history of uncontrolled seizures, central nervous system disorders
• Uncontrolled serious medical or psychiatric illness
• Women must not be pregnant or lactating
• Concurrent radiation therapy
• Other active malignancy
• Inability to swallow tablets
• Patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome
• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Roche Global Development

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Dana-Farber Cancer Institute

Principal Investigators

Matthew Kulke, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

03-070

Identifier Type: -

Identifier Source: org_study_id