Clinical trial · Interventional
Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer
Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer
- 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)
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with oxaliplatin and docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Biological | Bevacizumab | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel, Oxaliplatin & Bevacizumab
- description
- Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
- interventionNames
- Biological: Bevacizumab
- Drug: Docetaxel
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Time to Progression
- timeFrame
- After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
- description
- Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed gastric or gastroesophageal junction adenocarcinoma * Locally advanced unresectable or metastatic disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10mm by spiral CT scan * Bone metastases, ascites, or pleural effusions are not considered measurable disease * Evaluable disease must be present outside previously irradiated field * No CNS or brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * SWOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 mg/dL * No evidence of bleeding diathesis or coagulopathy Hepatic * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ ULN * INR \< 1.5 Renal * Creatinine \< 2.0 mg/dL * Urine protein:creatinine ratio \< 1.0 Cardiovascular * No history of deep venous thrombosis requiring anticoagulation * No active angina * No myocardial infarction within the past year * No cerebrovascular accident within the past year * No uncontrolled hypertension (systolic blood pressure \[BP\] \> 170 mm Hg and/or diastolic BP \> 100 mm Hg) despite medical management Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No peripheral neuropathy \> grade 1 * No history of allergy to any of the study drugs or drugs formulated with polysorbate 80 * No known HIV infection * No active peptic ulcer disease * No serious non-healing wound, ulcer, or bone fracture * No unresolved bacterial infection requiring antibiotics * No other active malignancy within the past 3 years except for cancers that have been treated with a curative intent PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * No prior chemotherapy for gastric cancer unless disease relapsed \> 6 months after completion of non-taxane adjuvant chemotherapy * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 weeks since radiotherapy Surgery * At least 4 weeks since prior surgery or open biopsy (except indwelling venous catheter placement) * No concurrent surgery Other * At least 4 weeks since prior and no concurrent participation in another experimental drug trial * No concurrent full-dose anticoagulation * No concurrent experimental drugs
References
Publications (0)
Data not yet available