Phase 2
N=75
VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer
Recurrent Colon Cancer · Recurrent Rectal Cancer · Stage IV Colon Cancer · Stage IV Rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00407654 ↗Enrolled (actual)
75
Serious AEs
25.3%
Results posted
Aug 2015
Primary outcome: Primary: Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria) — 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- aflibercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria) |
1 | — |
| PRIMARY Progression-free Survival (Bevacizumab- naïve Group) |
2.0 | — |
| PRIMARY Progression-free Survival (Bevacizumab-treated Group) |
2.4 | — |
| SECONDARY Overall Survival (Bevacizumab-naïve Group) |
10.4 | — |
| SECONDARY Overall Survival (Prior Bevacizumab Treated Group) |
8.5 | — |
| SECONDARY Time to Progression |
— | — |
| SECONDARY Objective Stable Disease Rate |
— | — |
| SECONDARY Number of Participants With Response (Bevacizumab-naïve Group) |
5 | — |
| SECONDARY Overall Survival (Bevacizumab-treated Group) |
8.5 | — |
| SECONDARY Overall Survival (Bevacizumab-treated Group) |
8.5 | — |
| SECONDARY Number of Participants With Response (Bevacizumab-treated Group) |
6 | — |
Summary
This phase II trial is studying how well VEGF Trap works in treating patients with previously treated metastatic colorectal cancer. VEGF Trap may stop the growth of colorectal cancer by blocking blood flow to the tumor.
Eligibility Criteria
Inclusion Criteria
- histologically/cytologically confirmed metastatic colorectal metastatic cancer
- measurable disease (at least 1 lesion accurately measured in at least 1 dimension (longest diameter) as>20mm with conventional techniques or as >10mm with spiral CT scan
- >=4 weeks from major surgery
- at least 1prior line of systemic therapy for metastatic disease. Prior treatment with anti-epidermal growth factor receptor inhibitors is allowed. Last dose >=4 weeks prior to randomization
- Two cohorts: 1) bevacizumab naïveand; 2) bevacizumab treated
- May have received prior thymidylate synthetase inhibitor concurrently with radiation as "radiation sensitizer". Last dose >=4 weeks prior to randomization
- Prior radiation treatment >=4 weeks prior to randomization
- Age>=18 years
- Life expectancy >=3 months
- ECOG 3.0x10^9/L
- absolute neutrophil count >1.5 x 10^9/L
- platelets>75x10^9/L
- INR 60mL/min/1.73m2 for patients with creatinine levels above1.5x institution limits
- Urinalysis negative for protein OR 24h urine for protein 1.5 eligible provided that: a) patient is therapeutic on stable dose of warfarin or low molecular weight heparin; b) patients on warfarin, the upper target for INR is 1.5 unless the patient is on full-dose warfarin
- Use of thrombolytic agents within 1 month of study initiation
- Significant Proteinuria (>500mg/24h): Urine protein should be screened by random urinalysis for protein. If dipstick positive (>1+), 24-hour urine protein should be obtained and if >500mg/24 h, patient will be excluded.
- Uncontrolled intercurrent illness including but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study
- Pregnant women
- HIV-positive patients on combination antiretroviral therapy are ineligible because of potential for PK interactions with VEGF Trap
Data sourced from ClinicalTrials.gov (NCT00407654). 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.