Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with metastatic or unresectable pancreatic cancer.
Drug: gemcitabine hydrochloride
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer|
- Progression-free Survival [ Time Frame: every 2-4 months for 1 year and then every 6 months for 5 years ] [ Designated as safety issue: No ]Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
- Percentage of Participants With Grades 3-5 Treatment Related Toxicities [ Time Frame: Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years ] [ Designated as safety issue: Yes ]Grade 3, 4 or 5 toxicity rate
- Percentage of Participants With Improved Quality of Life [ Time Frame: assessed at baseline then weekly for 3 weeks ] [ Designated as safety issue: No ]Quality of Life was assessed using EORTC QLQ-PAN26. All measures range in score from 1 to 4 as lower scores indicate better outcomes. The improved Quality of Life is defined as a greater than 5% decrease in 2 consecutive scores compared with the baseline score.
- Clinical Response [ Time Frame: Pre-treatment and every 6 weeks from treatment. ] [ Designated as safety issue: No ]Response was evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Overall Response (OR) = CR + PR.
- Overall Survival [ Time Frame: every 2-4 months for 1 year and then every 6 months for 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
- Determine progression-free survival of patients with metastatic or unresectable adenocarcinoma of the pancreas treated with gemcitabine, capecitabine, and bevacizumab.
- Determine clinical response in patients treated with this regimen.
- Determine toxicity of this regimen in these patients.
- Determine quality of life of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1, oral capecitabine twice daily on days 1-14, and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline then weekly for 3 weeks.
Patients are followed every 2-4 months for 1 year and then every 6 months for at least 5 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 8.8-17.5 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100815
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-1714|
|Principal Investigator:||Renuka Iyer, MD||Roswell Park Cancer Institute|