Tarceva and Capecitabine for Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer

Conditions
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Pancreatic Cancer, Neoplasm Metastasis

Intervention / Treatment
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* Drug: Capecitabine
* Drug: OSI-774


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine|Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).|
|Drug: OSI-774|Given once daily|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer |  | 2 years | 
| to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Second Line Therapy, Gemcitabine Refractory, Pancreatic Cancer, Capecitabine, Tarceva, OSI-774, Metastatic Pancreatic Cancer