Tarceva and Capecitabine for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125021
• Other study ID #: 03-070
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2005
• Last updated: October 30, 2009
• Start date: October 2003
• Est. completion date: September 2008

Study information

• Verified date: October 2009
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2008
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Massachusetts General Hospital, Roche Global Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer		TBD	No
Secondary	To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer		2 years	Yes
Secondary	to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774		TBD	No