Tarceva and Capecitabine for Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Roche Global Development
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00125021
First received: July 27, 2005
Last updated: October 30, 2009
Last verified: October 2009

July 27, 2005
October 30, 2009
October 2003
June 2004   (final data collection date for primary outcome measure)
To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer [ Time Frame: TBD ] [ Designated as safety issue: No ]
To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer.
Complete list of historical versions of study NCT00125021 on ClinicalTrials.gov Archive Site
  • To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774 [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer
  • to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774.
Not Provided
Not Provided
 
Tarceva and Capecitabine for Pancreatic Cancer
A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer

This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating 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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Cancer
  • Neoplasm Metastasis
  • Drug: Capecitabine
    Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).
  • Drug: OSI-774
    Given once daily
    Other Name: Tarceva
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2008
June 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00125021
03-070
Not Provided
Matthew Kulke, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Genentech, Inc.
  • Roche Global Development
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
Principal Investigator: Matthew Kulke, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP