Clinical trial NCT00125021: Tarceva and Capecitabine for Pancreatic Cancer
Official title: A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Neoplasm Metastasis
Keywords: Second Line Therapy
Gemcitabine Refractory
Pancreatic Cancer
Capecitabine
Tarceva
OSI-774
Metastatic Pancreatic Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Roche Global Development
name: Brigham and Women's Hospital
name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2005-07-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer
Secondary outcomes:
measure: To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer
timeFrame: 2 years
measure: to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Matthew Kulke, MD
role: PRINCIPAL_INVESTIGATOR
References: