oesophageal cancer oesophagogastric cancer
Conditions
Interventions
Regorafenib tolerability will be tested in a dose escalation scheme with a
cytotoxic backbone of paclitaxel 80mg/m2. The dose of regorafenib will be
escalated in fixed increments according to the sc
oesophagogastric cancer
paclitaxel
regorafenib
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Patient must understand, be willing to give consent, and sign a written informed consent form prior to undergoing any study-specific procedure * Male or female and * 18 years of age * Metastastic or non-resectable adeno- or squamous-cell carcinoma of the stomach or oesophagus who failed on first line cytotoxic treatment with a fluoropyrimidine and platinum compound * Tumor accessible for repeated biopsies (expansion cohort only) * Measurable disease * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group performance status of 0 or 1 (within14 days prior to the initiation of study treatment) * Have adequate bone marrow, liver function, and renal function
Exclusion criteria
Exclusion criteria: * Prior treatment with regorafenib * Contra-indications for repeated biopsies * Dementia or altered mental status that would prohibit the understanding and giving of informed consent * Have unresolved toxicity higher than National Cancer Institute-Common Terminology for Adverse Events version 4.0 (NCI-CTCAE v 4.0) Grade 1 attributed to any prior therapy/procedure, excluding alopecia. * Have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment * * Have currently suspected brain metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| * Paclitaxel concentration in tumor biopsy * Paclitaxel pharmacokinetics * Expression of regorafenib targets in tumor biopsy samples * Progression free survival * Overall survival | — |
Countries
The Netherlands
Outcome results
None listed