Clinical trial · Interventional
Bortezomib, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer
A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma
- 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: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with fluorouracil and leucovorin works in treating patients with metastatic or unresectable stomach cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate as measured by RECIST every 8 weeks
Secondary outcomes (4)
- measure
- Time to progression every 8 weeks
- measure
- Overall survival
- measure
- Toxicity every 4 weeks
- measure
- Molecular correlates on and off study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of gastric or gastroesophageal junction adenocarcinoma * Metastatic or unresectable disease * Progressive disease after receiving 1 prior chemotherapy regimen for metastatic disease comprising 1 of the following: * Fluorouracil * Cisplatin and irinotecan * Capecitabine * Taxanes * Measurable disease * No esophageal cancer * No brain metastases PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No acute ischemia by EKG * No significant conduction abnormality by EKG, including either of the following: * Bifasicular block, defined as left anterior hemiblock in the presence of right bundle branch block * Second or third degree atrioventricular block * No history of cardiac or cerebrovascular disease due to hypotension and tachycardia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception before, during, and for 6 months after study participation * No ongoing or active infection * No other uncontrolled illness * No peripheral neuropathy ≥ grade 2 within the past 2 weeks * No allergy to boron or mannitol PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * More than 2 weeks since prior major surgery Other * No concurrent highly active anti-retroviral therapy for HIV-positive patients * No other concurrent investigational agents
References
Publications (0)
Data not yet available