Phase 2
N=42
Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00417976 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Nov 2014
Primary outcome: Primary: Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy — 49 percent of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); Bevacizumab (Drug); Infusional 5-Fluorouracil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tony Bekaii-Saab
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy |
49 | — |
| SECONDARY Response Rates Defined by RECIST 1.0 |
0; 12; 18; 10 | — |
Summary
This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure response.
Eligibility Criteria
Inclusion Criteria
- Males or females age >=18 years.
- Established histological confirmation of adenocarcinoma of the pancreas.
- Stage III and stage IV will be allowed.
Exclusion Criteria
- No prior chemotherapy or radiotherapy allowed except for that given as part of an adjuvant regimen if >4 weeks have elapsed since the end of therapy. Any prior treatment with antibodies to VEGF.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting the study.
- Pregnant or lactating women.
Data sourced from ClinicalTrials.gov (NCT00417976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.