Clinical trial · Interventional
Trial of Panitumumab Cisplatin, Fluourouracil and Docetaxel in Locally Advanced or Metastatic Gastric Cancer
Phase I/II, Multicenter, Single-Arm Clinical Trial of Panitumumab in Combination With Cisplatin, Fluourouracil and Docetaxel (DCF) in Locally Advanced or Metastatic Cancer of the Stomach and Gastro-oesophageal Junction.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not reached the primary endpoint target according to the statistical design
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pazopanib | Drug | Pazopanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Panitumumab plus DCF
- interventionNames
- Drug: Pazopanib
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- Every 8 weeks
- description
- 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 outcomes (3)
- measure
- Progression Free Survival
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available