Tarceva and Capecitabine for Pancreatic Cancer

NCT00125021 | Completed Phase 2

• 1 other identifier: 03-070
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Pancreatic Cancer; Neoplasm Metastasis

Keywords

Second Line Therapy; Gemcitabine Refractory; Pancreatic Cancer; Capecitabine; Tarceva; OSI-774; Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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

Interventions

Capecitabine DRUG

Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).

OSI-774 DRUG

Given once daily

Also known as: Tarceva

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Genentech, Inc.: collaborator
• Roche Global Development: collaborator
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

Capecitabine; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Matthew Kulke, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2005
• First Posted: July 29, 2005
• Study Start: October 1, 2003
• Primary Completion: June 1, 2004
• Study Completion: September 1, 2008
• Last Updated: November 2, 2009

Record last verified: 2009-10

Locations

US (3)