Phase 2
N=83
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.
Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00448136 ↗Enrolled (actual)
83
Serious AEs
28.9%
Results posted
Jan 2015
Primary outcome: Primary: Progression-Free Survival (PFS) - Percentage of Participants With an Event — 52.9; 53.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab [Avastin] (Drug); 5 FU (Drug); Streptozotocin (Drug); Xeloda (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) - Percentage of Participants With an Event |
52.9; 53.1 | — |
| PRIMARY PFS - Time to Event |
23.7; 23.4 | — |
| PRIMARY PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months |
76; 65; 50; 48 | — |
| SECONDARY Percentage of Participants With a Response by Best Overall Response |
55.9; 18.4; 51.5; 12.5; 44.1; 69.4 | — |
| SECONDARY Duration of Overall Response (OR) - Percentage of Participants With an Event |
42.1; 22.2 | — |
| SECONDARY Duration of OR - Time to Event |
NA; NA | — |
| SECONDARY Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months |
74; 70; 55; NA | — |
| SECONDARY Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event |
52.9; 46.5 | — |
| SECONDARY Duration of ODC - Time to Event |
22.3; 23.4 | — |
| SECONDARY Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months |
68; 72; 42; NA | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event |
14.7; 16.3 | — |
| SECONDARY OS - Time to Event |
NA; NA | — |
| SECONDARY OS - Percentage of Participants Surviving at 12 and 24 Months |
94; 88; 88; 85 | — |
| SECONDARY Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30) |
65.23; 65.42; 65.83; 57.03; 60.00; 66.32 | — |
| SECONDARY Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category |
10.0; 17.2; 10.0; 24.1; 10.0; 17.2 | — |
| SECONDARY EORTC QLQ-C30 Functional and Symptom Scale Scores |
90.44; 87.71; 89.32; 75.35; 81.98; 82.50 | — |
Summary
This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks. Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- well-differentiated gastrointestinal tract endocrine tumors, or duodeno-pancreatic endocrine tumors;
- no previous anti-cancer therapy, other than surgery;
- progressive metastatic disease;
- >=1 measurable lesion.
Exclusion Criteria
- abnormal cardiac function, with history of ischemic heart disease in past 6 months and/or abnormal 12 lead ECG;
- patients with known bleeding disorders;
- unstable systemic disease;
- chronic daily treatment with high-dose aspirin, NSAIDs or corticosteroids;
- previous history of malignancy (other than successfully treated basal and squamous cell cancer of the skin, and/or in situ cancer of the cervix).
Data sourced from ClinicalTrials.gov (NCT00448136). 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.