Tarceva and Capecitabine for Pancreatic Cancer
- Conditions
- Pancreatic CancerNeoplasm Metastasis
- Registration Number
- NCT00125021
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
-
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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States