Gastric Cancer
Conditions
Keywords
Advanced cancer of the stomach, Chemotherapy - naive patients, DCF
Brief summary
Investigators propose to study the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients with advanced cancer of the stomach.
Detailed description
Investigators propose a phase I/II study in order to evaluate the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in chemotherapy - naive patients with advanced cancer of the stomach. Investigators hypothesize that the addition of panitumumab to DCF regimen in advanced cancer of the stomach and gastroesophageal junction is feasible, well tolerated and could achieve an objective response rate of greater than 40%. The 2-weekly schedule of DCF will be used as chemotherapy since a recently presented trial demonstrated a comparable efficacy but a more favourable toxicity profile comparable to the 3-weekly schedule.
Interventions
DRUGPazopanib
Sponsors
Hellenic Oncology Research Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction) * Patient's age between 20 and 70 years old * Measurable disease defined by RECIST criteria * Patients with non-measurable disease could be enrolled in the phase I part of the study * ECOG performance status ≤ 1 * Hgb ≥ 8g/dL, WBC ≥ 3 x 109/L , neutrophils count ≥ 1.5 x 109/L , platelets ≥100 x 109/L, Creatinine clearance ≥50 mL/min, Total bilirubin ≤ 1.5 X UNL, AST, ALT and ALP ≤ 2.5 x UNL * No prior chemotherapy or more than 6 months from adjuvant chemotherapy or chemo-radiation * Estimated life expectancy more than 3 months * Written informed consent
Exclusion criteria
* Gastrointestinal bleeding * Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort * CNS metastases * History of hypersensitivity to fluoropyrimidines, docetaxel or platinum compounds * Any previous chemotherapy or radiotherapy for advanced disease * Patient pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment * Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment * Known hypersensitivity reaction to the component of the treatment * Active infection or malnutrition or bowel obstruction * Legal incapacity or limited legal capacity * Definite contraindications for the use of corticosteroids * History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan * Chronic inflammation of the bowel * Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment * Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent * A second primary tumor other than non-melanoma skin cancer or in situ cervical cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Every 8 weeks | Patients will be followed for disease evaluation every eight (8) weeks from the first day of chemotherapy until the first documentation of disease progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 1 year | Patients will be evaluated from the date of the first chemotherapy cycle until the date of first documented progression or date of death from any cause, whichever came first |
| Overall Survival | 1 year | Patients will be evaluated for overall survival from the date of the first chemotherapy cycle until the date of death from any cause |
| Maximum Tolerated Dose of the combination | Up to 4 weeks | Patients will be evaluated for toxicity profil on Day 1 of the first two chemotherapy cycle (cycle repeated every 2 weeks) |
Countries
Greece
Outcome results
None listed