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Status:

COMPLETED

Tarceva and Capecitabine for Pancreatic Cancer

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborating Sponsors:

Genentech, Inc.

Roche Global Development

Conditions:

Pancreatic Cancer

Neoplasm Metastasis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2008

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT00125021

Start Date

October 1 2003

End Date

September 1 2008

Last Update

November 2 2009

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

2

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02115

3

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02115