Clinical trial · Interventional
Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer
Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum
NCT01238055CI-TRIAL-00009966completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in the treatment of advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinum.
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 |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel only | Drug | — | UNRESOLVED |
| Docetaxel + Sunitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Docetaxel + Sunitinib
- description
- Docetaxel and Sunitinib
- interventionNames
- Drug: Docetaxel + Sunitinib
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- description
- Docetaxel only
- interventionNames
- Drug: Docetaxel only
Primary outcomes (1)
- measure
- time to progression
- timeFrame
- every 6 weeks
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with \> 50% extension in the stomach) 2. patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred 3. prior chemotherapy wit fluoropyrimidine and platinum 4. measurable or evaluable disease according to RECIST 5. age, 18 years or older 6. ECOG performance status 0 - 2 7. adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 2.0 mg/dL 8. life expectancy of ≥ 3 months 9. signed written informed consent Exclusion Criteria: 1. more than one prior chemotherapy for metastatic disease 2. severe co-morbid illness and/or active infections 3. NCI CTCAE Grade 3 hemorrhage from any cause \< 4 weeks before enrollment 4. preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart 5. pregnant or lactating women 6. active CNS metastases not controllable with radiotherapy or corticosteroids 7. active and uncontrollable bleeding from gastrointestinal tract 8. known history of hypersensitivity to study drugs 9. prior treatment with sunitinib
References
Publications (0)
Data not yet available
No reference posted for this study.