Neoplasm Metastasis, Pancreatic Cancer
Conditions
Keywords
Second Line Therapy, Gemcitabine Refractory, Pancreatic Cancer, Capecitabine, Tarceva, OSI-774, Metastatic Pancreatic Cancer
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.
Interventions
DRUGCapecitabine
Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).
DRUGOSI-774
Given once daily
Sponsors
Genentech, Inc.
Roche Global Development
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer | — |
Secondary
| Measure | 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 | — |
Countries
United States
Outcome results
None listed