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

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer, Neoplasm Metastasis

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Trial Information

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

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.

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer

Outcome Time Frame:


Safety Issue:


Principal Investigator

Matthew Kulke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2003

Completion Date:

September 2008

Related Keywords:

  • Pancreatic Cancer
  • Neoplasm Metastasis
  • Second Line Therapy
  • Gemcitabine Refractory
  • Pancreatic Cancer
  • Capecitabine
  • Tarceva
  • OSI-774
  • Metastatic Pancreatic Cancer
  • Neoplasms
  • Neoplasm Metastasis
  • Pancreatic Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617