Colorectal Cancer MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Zaltrap
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: Aflibercept
CAS Number: 862111328
Current Sponsor code: AVE0005
Other descriptive name:
Sponsors
Guys & St. Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed colorectal cancer with evidence of metastatic disease Adequate medical fitness to undergo fluoropyrimidine-based chemotherapy. No known dihydropyrimidine dehydrogenase deficiency. Adequate bone marrow function with: platelets > 100 x 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/l; Hb > 9 g/dl Serum bilirubin 50ml/min Proteinuria 3 months Age = 18 years Phase I study specific criteria WHO performance status 0 – 1 Progressive disease after at least first line chemotherapy treatment Previous fluoropyrimidine therapy has not required dose reduction of greater than 25%, significant delay (= 7 days) or stopped treatment due to fluoropyrimidine toxicity Phase 2 specific criteria WHO performance status 0 – 2 ? Patients not deemed suitable for doublet/triplet combination chemotherapy. ? No previous treatment for mCRC. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: Known evidence of brain metastases o Liver-only metastatic disease deemed to be resectable o LVEF 1.5) in the absence of vitamin K antagonist therapy. o Intolerance to loperamide o Previous history of gastrointestinal fistula or perforation o Evidence of bowel obstruction o Clinically relevant history of drug or alcohol abuse o Serious uncontrolled inter current illness including poorly controlled diabetes mellitus o HIV, HBV or HCV infection. o Pregnancy or lactation. Men and women of child-bearing potential must use adequate contraception Any psychological, familial, sociological or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: phase 1 To evaluate the maximum tolerated dose in a selected group of patients with good performance status with metastatic disease who have progressed on at least first line therapy. phase 2 To establish safety and tolerability of recommended phase II treatment dose of aflibercept and capecitabine in patients not suitable for doublet/triplet cytotoxic chemotherapy;Secondary Objective: phase 1 To evaluate the overall treatment toxicity profile in this group. Overall response rate in this group phase 2 To establish the overall response rate (ORR) in this group To assess the overall treatment utility of this combination via the use of a comprehensive health assessment tool. To evaluate the overall treatment toxicity profile according to the CTC v4.03. To assess progression free survival in this group ;Primary end point(s): phase 1 o To establish the maximum tolerated dose and dose-limiting toxicities in this group phase 2 o Tolerability and feasbility of treatment (no dose reduction, significant treatment delay or stopping treatment early due to toxicity).;Timepoint(s) of evaluation of this end point: Toxicity will be assessed prior to each cycle of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): phase 1 o To evaluate the overall treatment toxicity profile in this group phase 2 o Overall response rate o Progression free survival o Dose limiting toxicities. o Quality of life o Overall treatment utility via the use of comprehensive health assessment tool ;Timepoint(s) of evaluation of this end point: post study analysis | — |
Countries
United Kingdom
Contacts
Public ContactPaul Ross
Guys & St. Thomas' NHS Foundation Trust
Outcome results
None listed